Cancer, Pain
Conditions
Keywords
Cancer pain, Anesthesiology, Opiates, Intranasal ketamine
Brief summary
The main purpose of this study is to determine the safety, feasibility, and utility of intranasal (NAS) ketamine in persistent uncontrolled cancer related pain. In this prospective clinical trial the researchers will investigate the use of NAS ketamine in patients with pain related to cancer or cancer treatment. The researchers plan to enroll at least 25 patients meeting inclusion/exclusion criteria, to achieve a minimum of 10 patients who complete the study. Participants will be recruited from the supportive oncology clinic, oncology clinics, the pain clinic and Acute Pain Service at Emory. Participants will be asked to return to the Phase I unit of the Winship Cancer Building C for a total of 5 study visits, each two to five days apart. During these visits participants will complete questionnaires, have blood samples drawn and will have study medication administered to them in escalating doses. For safety monitoring participants will be contacted by telephone 14 days after the last dose of medication administered.
Detailed description
There are about 11.9 million Americans affected with cancer. 53% of patients with cancer experience pain at all stages of cancer. These patients often require high doses of opioids with uncontrolled pain that makes them too sedated to effectively participate in day-to-day activities and have a good quality of life. Depression often co-exists with cancer pain due to the nature of the disease. The researchers are searching for improved therapies for chronic cancer pain and ketamine with its novel mechanism of action may be a promising solution. Ketamine is an FDA approved anesthetic with the ability to effect memory loss, pain relief and sedation. Safety and efficacy of ketamine as an anesthetic and analgesic agent is well documented. Low doses of ketamine have minimal adverse impact on circulatory or breathing functions but can reduce pain. Research has shown that ketamine is effective in controlling breakthrough pain and reducing depression in a randomized double blind controlled trial. There is limited data regarding the use of ketamine for pain management in cancer. One of the challenges with ketamine is the route of administration, most commonly given intravenously (IV) or intramuscularly (IM). It has also been given by mouth and rectally, but absorption is very poor. Intranasal (NAS) administration may be a promising method of delivery and can be ordered by a physician from a compounding pharmacy. From other research the investigators expect absorption to be higher than oral or rectal administration and this method of delivery as needle-free is a patient-friendly route of administration. The main purpose of this study is to determine the safety, feasibility, and utility of intranasal (NAS) ketamine in persistent uncontrolled cancer related pain. In this prospective clinical trial the researchers will investigate the use of NAS ketamine in patients with pain related to cancer or cancer treatment. The researchers plan to enroll at least 15 patients meeting inclusion/exclusion criteria, to achieve a minimum of 10 patients who complete the study. Participants will be recruited from the oncology clinic, pain clinic and Acute Pain Service at Emory. Participants will be asked to return to the Phase I unit of the Winship Cancer Building C for a total of 5 study visits, each two to five days apart. During these visits participants will complete questionnaires, have blood samples drawn and will have study medication administered to them in escalating doses. For safety monitoring participants will be contacted by telephone 14 days after the last dose of medication administered. Data obtained from this study will help determine if ketamine provides a reduction of pain using the Numeric Pain Rating Scale and a reduction in the use of opioid consumption and other rescue medications. Additionally the researchers will study the bioavailability, pharmacodynamics and pharmacokinetics of ketamine and the safety profile of NAS ketamine.
Interventions
DRUGIntranasal ketamine
10mg of intranasal ketamine will be given to make sure that the study patients are able to tolerate a small dose of NAS ketamine. On the second visit, 10 mg of IV ketamine will be given to help establish bioavailability of NAS ketamine, with patients serving as their own controls. On the third and fourth visit, higher doses of ketamine, 30 mg and 50 mg respectively, will be given. All doses of ketamine will be administered by an anesthesia research nurse.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with uncontrolled pain related to cancer or cancer treatment. Uncontrolled pain will be defined as: * Pain which persists for more than 7 days and is rated \>/=4 on Numerical Pain Rating Score (NPRS) * Use of breakthrough medication more than 4 times in 24 hours or being treated with oral morphine equivalent of 50 mg/d or more * Patients who are able to follow-up in person during the trial * Patient on stable analgesic regimen for \>7 days without escalation during study period with rescue or immediate release medication every 3 hours or longer * Patients who are willing and able to maintain a daily pain diary * Patients who are able to understand written and verbal English * Patient weight \>/= 50 kg
Exclusion criteria
* Transportation issues interfering with return study visits * Patients with high disposition of laryngospasm or apnea * Presence of severe cardiac disease * Presence of conditions where significant elevations in blood pressure would be a serious hazard. * Stage 2 hypertension or greater (systolic blood pressure \> 160 and/or diastolic blood pressure \>100) * Baseline tachycardia, heart rate (HR) \>100 * History of seizures, elevated intracranial pressure (ICP) or cerebrospinal fluid (CSF) obstructive states (e.g. severe head injury, central congenital or mass lesions) * Conditions that may increase intraocular pressure (e.g. glaucoma, acute globe injury) * History of uncontrolled depression or other psychiatric comorbidity with psychosis * History of liver disease * History of interstitial cystitis * History of nasal or sinus anomalies or dysfunction e.g. allergic or infectious rhinitis. * Patients with lesions to the nasal mucosa * Pregnant women, nursing mothers and women of childbearing potential not using contraception known to be highly effective. Highly effective contraception methods include combination of any two of the following: * Use of oral, injected or implanted hormonal methods of contraception or; * Placement of an intrauterine device (IUD) or intrauterine system (IUS); * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository; * Total abstinence or; * Male/female sterilization. * Illicit substance abuse within the past 6 months * Documented history of medication abuse/misuse (e.g. Unsanctioned dose escalation, broken opioid agreement etc.) * Clinical requirement for medications that are concurrent inducers or inhibitors of CYP3A4. CYP3A4 substrates are allowed. * Porphyria (possibility of triggering a porphyric reaction) * Severe active anemia ( a hemoglobin\< 8 documented by labs drawn within 3 months of first study treatment) * History of difficult intravenous access * Intractable vomiting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score | Baseline during Visit 1 and Visit 5, up to 6 weeks | The PROMIS Global Health questionnaire, version 1.1, consists of 10 items assessing general domains of health and functioning. Items are scored on a 5-point scale where 1 = poor and 5 = excellent. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better health and functioning, while scores below 50 indicate physical, mental and social health that is below average. |
| Edmonton Symptom Assessment System (ESAS) Score | Baseline during Study Visits 1 through 5, up to 6 weeks | The Edmonton Symptom Assessment System (ESAS) assesses nine symptoms that are common in cancer patients: pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, and well-being. Each symptom is rated on a scale ranging from 0 (absence of symptom) to 10 (worst possible degree of symptom). The ESAS was administered at the baseline time point at each study visit. |
| Eastern Cooperative Oncology Group (ECOG) Score | Baseline during Visits 1 through 4, up to 4 weeks | The Eastern Cooperative Oncology Group (ECOG) score evaluates performance status of the participants by rating their ability to perform physical tasks and self care. Responses are 0 (fully active), 1 (restricted in physical strenuous activity but ambulatory), 2 (ambulatory and capable of all self-care but unable to carry out work activities), 3 (capable of only limited self-care), 4 (completely disabled), or 5 (dead). The ECOG score will be obtained at the baseline time point at each study visit where medication is administered. |
| Bioavailability of Ketamine | Baseline, Minutes 2, 30, 60, and 240 during Study Visits 1 through 4, up to 4 weeks | Blood samples were obtained at the study visits where ketamine was administered to measure the bioavailability (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Bioavailability is assessed as nanograms per milliliter (ng/mL) of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained prior to ketamine administration, and at 2, 30, 60 and 240 minutes after medication administration, during study visits 1 through 4. The baseline sample was not collected at the first study visit as assessing prior intake of ketamine was not necessary. |
| Peak Concentration (Cmax) of Ketamine | Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 weeks | Blood samples were obtained at the study visits where ketamine was administered to measure the peak concentration (Cmax) of intranasal and intravenous ketamine. Peak concentration is assessed as the maximum ng/mL of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained at 2, 30, 60 and 240 minutes after medication administration. |
| Area Under the Curve of Ketamine | Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 Weeks | Blood samples were obtained at the study visits where ketamine was administered to measure the elimination (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Elimination of the drug disappearing from the body is assessed as the area under the curve (AUC). Each study participant received each dose of ketamine during separate study visits. Samples were obtained at 2, 30, 60 and 240 minutes after medication administration. Each subject did not have quantitative levels at all time points. There were not enough data to construct a curve for each participant and therefore calculate an AUC. Data from all participants were naively pooled to calculate one AUC for the entire population (i.e., across all participants' data). |
| Time to Peak Concentration (Tmax) of Ketamine | Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 weeks | Blood samples were obtained at the study visits where ketamine was administered to measure the time to peak concentration (Tmax) of intranasal and intravenous ketamine. Time is measured as minutes after administration when the maximum concentration of ketamine in blood is reached. |
| Numerical Pain Rating Scale (NPRS) Score | Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, and 240 during Study Visits 1 through 4, up to 4 weeks | The Numerical Pain Rating Scale (NPRS) was used to evaluate patient reported pain. Pain scores were recorded prior to and at 5,10,15, 30, 45, 60, 120, 180 and 240 minutes after administration of ketamine. The NPRS asks participants rate their current level of pain intensity on a scale from 0 (no pain) to 10 (worst possible pain). In general, improvements of pain severity of 1.5 points or less on NPRS could be seen as clinically irrelevant. Above that value, the cutoff point for clinical relevance depends on patients' baseline pain severity, and ranges from 2.4 to 5.3. Higher baseline scores require larger raw changes to represent clinically important differences. |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported fatigue, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported dizziness, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported nausea, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported headache, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported feeling of unreality, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported change in hearing, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported change in vision, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported mood change, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported general discomfort, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks | To evaluate self-reported hallucinations, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome). |
| Montgomery Asberg Depression Rating Scale (MADRS) Score | Baseline and Minute 180, during Study Visits 1 through 5, up to 6 weeks | Depression was assessed on the Montgomery Asberg Depression Rating Scale (MADRS) during each study visit, before medication administration and 180 minutes after medication administration. The MADRS is designed to be particularly sensitive to treatment effects. The MADRS is a 10-item scale where the survey administrator rates the participant on a variety of aspects related to depression (such as apparent sadness, tension, and pessimistic thoughts) based on a clinical interview. Responses are provided on a scale of 0 to 6 where 0 signifies no difficulties in this area and 6 signifies severe difficulty. Total scores range from 0 to 60 with higher scores indicating greater severity of depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | Visit 1 through Visit 5, up to 6 weeks | The opioid sparing effect of NAS ketamine will be determined by evaluating total opioid consumption (rescue medication) prior to and during the study. |
| Frequency of Rescue Medication Use | Visit 1 through Visit 5, up to 6 weeks | The opioid sparing effect of NAS ketamine will be determined by evaluating frequency of rescue medications use prior to and during the study. |
Countries
United States
Participant flow
Recruitment details
Participants will be recruited from the supportive oncology clinic, oncology clinics, and pain clinics at Emory University in Atlanta, Georgia. Participant enrollment began July 25, 2017 and all follow up was complete by April 22, 2020.
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Ketamine Treatment Study participants receiving three different doses of intranasal ketamine and one dose of IV ketamine, at four different study visits, for treatment of cancer pain. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Intranasal Ketamine Treatment |
|---|---|
| Age, Continuous | 49.5 years |
| Cancer Type Bone | 2 Participants |
| Cancer Type Breast | 4 Participants |
| Cancer Type Colon | 1 Participants |
| Cancer Type Larynx | 1 Participants |
| Cancer Type Lung | 1 Participants |
| Cancer Type Multiple myeloma | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Pain Type Mixed nociceptive and neuropathic pain | 5 Participants |
| Pain Type Neuropathic | 0 Participants |
| Pain Type Nociceptive | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 9 / 10 | 10 / 10 | 9 / 10 | 8 / 10 | 5 / 10 | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 | 1 / 10 | 0 / 10 | 2 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Area Under the Curve of Ketamine
Blood samples were obtained at the study visits where ketamine was administered to measure the elimination (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Elimination of the drug disappearing from the body is assessed as the area under the curve (AUC). Each study participant received each dose of ketamine during separate study visits. Samples were obtained at 2, 30, 60 and 240 minutes after medication administration. Each subject did not have quantitative levels at all time points. There were not enough data to construct a curve for each participant and therefore calculate an AUC. Data from all participants were naively pooled to calculate one AUC for the entire population (i.e., across all participants' data).
Time frame: Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 Weeks
Population: This analysis includes participants with viable samples. Some samples were not able to be reliably analyzed for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 10 mg Intranasal Ketamine | Area Under the Curve of Ketamine | 19 micrograms•hour/Liter (µg•h/L) |
| 10 mg Intravenous (IV) Ketamine | Area Under the Curve of Ketamine | 113 micrograms•hour/Liter (µg•h/L) |
| 30 mg Intranasal Ketamine | Area Under the Curve of Ketamine | 46 micrograms•hour/Liter (µg•h/L) |
| 50 mg Intranasal Ketamine | Area Under the Curve of Ketamine | 64 micrograms•hour/Liter (µg•h/L) |
Primary
Bioavailability of Ketamine
Blood samples were obtained at the study visits where ketamine was administered to measure the bioavailability (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Bioavailability is assessed as nanograms per milliliter (ng/mL) of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained prior to ketamine administration, and at 2, 30, 60 and 240 minutes after medication administration, during study visits 1 through 4. The baseline sample was not collected at the first study visit as assessing prior intake of ketamine was not necessary.
Time frame: Baseline, Minutes 2, 30, 60, and 240 during Study Visits 1 through 4, up to 4 weeks
Population: The baseline measurement was not collected during the visit where 10 mg of intranasal ketamine was administered. This analysis includes participants with viable samples. Some samples were not able to be reliably analyzed for this outcome.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Bioavailability of Ketamine | 2 minutes post-ketamine administration | 13.4 ng/mL | Standard Deviation 1.65 |
| 10 mg Intranasal Ketamine | Bioavailability of Ketamine | 240 minutes post-ketamine administration | 0 ng/mL | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Bioavailability of Ketamine | 30 minutes post-ketamine administration | 20.3 ng/mL | Standard Deviation 2.01 |
| 10 mg Intranasal Ketamine | Bioavailability of Ketamine | 60 minutes post-ketamine administration | 11.7 ng/mL | Standard Deviation 1.38 |
| 10 mg Intravenous (IV) Ketamine | Bioavailability of Ketamine | Baseline | 0 ng/mL | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Bioavailability of Ketamine | 30 minutes post-ketamine administration | 35.0 ng/mL | Standard Deviation 1.35 |
| 10 mg Intravenous (IV) Ketamine | Bioavailability of Ketamine | 60 minutes post-ketamine administration | 16.4 ng/mL | Standard Deviation 1.7 |
| 10 mg Intravenous (IV) Ketamine | Bioavailability of Ketamine | 2 minutes post-ketamine administration | 296.4 ng/mL | Standard Deviation 1.71 |
| 10 mg Intravenous (IV) Ketamine | Bioavailability of Ketamine | 240 minutes post-ketamine administration | 0 ng/mL | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Bioavailability of Ketamine | 30 minutes post-ketamine administration | 48.6 ng/mL | Standard Deviation 1.67 |
| 30 mg Intranasal Ketamine | Bioavailability of Ketamine | Baseline | 0 ng/mL | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Bioavailability of Ketamine | 2 minutes post-ketamine administration | 23.7 ng/mL | Standard Deviation 2.98 |
| 30 mg Intranasal Ketamine | Bioavailability of Ketamine | 60 minutes post-ketamine administration | 26.5 ng/mL | Standard Deviation 2.1 |
| 30 mg Intranasal Ketamine | Bioavailability of Ketamine | 240 minutes post-ketamine administration | 0 ng/mL | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Bioavailability of Ketamine | 60 minutes post-ketamine administration | 55.8 ng/mL | Standard Deviation 2.12 |
| 50 mg Intranasal Ketamine | Bioavailability of Ketamine | 2 minutes post-ketamine administration | 33.7 ng/mL | Standard Deviation 3.86 |
| 50 mg Intranasal Ketamine | Bioavailability of Ketamine | Baseline | 0 ng/mL | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Bioavailability of Ketamine | 30 minutes post-ketamine administration | 51.0 ng/mL | Standard Deviation 1.75 |
| 50 mg Intranasal Ketamine | Bioavailability of Ketamine | 240 minutes post-ketamine administration | 0 ng/mL | Standard Deviation 0 |
Primary
Eastern Cooperative Oncology Group (ECOG) Score
The Eastern Cooperative Oncology Group (ECOG) score evaluates performance status of the participants by rating their ability to perform physical tasks and self care. Responses are 0 (fully active), 1 (restricted in physical strenuous activity but ambulatory), 2 (ambulatory and capable of all self-care but unable to carry out work activities), 3 (capable of only limited self-care), 4 (completely disabled), or 5 (dead). The ECOG score will be obtained at the baseline time point at each study visit where medication is administered.
Time frame: Baseline during Visits 1 through 4, up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Intranasal Ketamine | Eastern Cooperative Oncology Group (ECOG) Score | 2.1 units on a scale | Standard Deviation 0.88 |
| 10 mg Intravenous (IV) Ketamine | Eastern Cooperative Oncology Group (ECOG) Score | 2.1 units on a scale | Standard Deviation 0.88 |
| 30 mg Intranasal Ketamine | Eastern Cooperative Oncology Group (ECOG) Score | 1.8 units on a scale | Standard Deviation 0.79 |
| 50 mg Intranasal Ketamine | Eastern Cooperative Oncology Group (ECOG) Score | 1.9 units on a scale | Standard Deviation 0.99 |
Primary
Edmonton Symptom Assessment System (ESAS) Score
The Edmonton Symptom Assessment System (ESAS) assesses nine symptoms that are common in cancer patients: pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, and well-being. Each symptom is rated on a scale ranging from 0 (absence of symptom) to 10 (worst possible degree of symptom). The ESAS was administered at the baseline time point at each study visit.
Time frame: Baseline during Study Visits 1 through 5, up to 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Nausea | 1.09 units on a scale | Standard Deviation 2.59 |
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Depression | 3.18 units on a scale | Standard Deviation 2.44 |
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Drowsiness | 4.64 units on a scale | Standard Deviation 2.98 |
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Tiredness | 6.09 units on a scale | Standard Deviation 1.92 |
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Well-being | 4.82 units on a scale | Standard Deviation 2.52 |
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Anxiety | 3.82 units on a scale | Standard Deviation 2.82 |
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Shortness of Breath | 1.55 units on a scale | Standard Deviation 2.7 |
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Pain | 6.64 units on a scale | Standard Deviation 1.96 |
| 10 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Lack of Appetite | 4.55 units on a scale | Standard Deviation 2.77 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Anxiety | 2.82 units on a scale | Standard Deviation 1.94 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Well-being | 4.45 units on a scale | Standard Deviation 2.88 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Pain | 6.27 units on a scale | Standard Deviation 2.1 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Drowsiness | 3.64 units on a scale | Standard Deviation 2.58 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Nausea | 0.82 units on a scale | Standard Deviation 1.6 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Lack of Appetite | 3.45 units on a scale | Standard Deviation 2.38 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Shortness of Breath | 1.09 units on a scale | Standard Deviation 1.97 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Depression | 2.45 units on a scale | Standard Deviation 1.86 |
| 10 mg Intravenous (IV) Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Tiredness | 4.73 units on a scale | Standard Deviation 2.57 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Nausea | 0.40 units on a scale | Standard Deviation 0.7 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Shortness of Breath | 0.40 units on a scale | Standard Deviation 1.26 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Depression | 1.50 units on a scale | Standard Deviation 1.51 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Lack of Appetite | 3.00 units on a scale | Standard Deviation 3.02 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Well-being | 4.20 units on a scale | Standard Deviation 2.2 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Tiredness | 4.20 units on a scale | Standard Deviation 2.44 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Drowsiness | 2.90 units on a scale | Standard Deviation 2.6 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Pain | 5.80 units on a scale | Standard Deviation 1.81 |
| 30 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Anxiety | 1.00 units on a scale | Standard Deviation 1.25 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Depression | 0.82 units on a scale | Standard Deviation 1.33 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Nausea | 0.227 units on a scale | Standard Deviation 0.65 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Pain | 5.73 units on a scale | Standard Deviation 2.53 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Shortness of Breath | 0.18 units on a scale | Standard Deviation 0.6 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Drowsiness | 3.64 units on a scale | Standard Deviation 2.5 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Anxiety | 1.27 units on a scale | Standard Deviation 1.68 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Lack of Appetite | 2.20 units on a scale | Standard Deviation 2.1 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Well-being | 4.09 units on a scale | Standard Deviation 2.66 |
| 50 mg Intranasal Ketamine | Edmonton Symptom Assessment System (ESAS) Score | Tiredness | 4.36 units on a scale | Standard Deviation 2.54 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Well-being | 4.60 units on a scale | Standard Deviation 2.27 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Pain | 5.30 units on a scale | Standard Deviation 1.89 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Tiredness | 3.60 units on a scale | Standard Deviation 2.11 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Drowsiness | 2.00 units on a scale | Standard Deviation 2.21 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Nausea | 0 units on a scale | Standard Deviation 0 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Lack of Appetite | 2.20 units on a scale | Standard Deviation 2.2 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Shortness of Breath | 0.60 units on a scale | Standard Deviation 0.97 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Depression | 2.10 units on a scale | Standard Deviation 3.41 |
| Follow-up Visit | Edmonton Symptom Assessment System (ESAS) Score | Anxiety | 0.60 units on a scale | Standard Deviation 0.97 |
Primary
Montgomery Asberg Depression Rating Scale (MADRS) Score
Depression was assessed on the Montgomery Asberg Depression Rating Scale (MADRS) during each study visit, before medication administration and 180 minutes after medication administration. The MADRS is designed to be particularly sensitive to treatment effects. The MADRS is a 10-item scale where the survey administrator rates the participant on a variety of aspects related to depression (such as apparent sadness, tension, and pessimistic thoughts) based on a clinical interview. Responses are provided on a scale of 0 to 6 where 0 signifies no difficulties in this area and 6 signifies severe difficulty. Total scores range from 0 to 60 with higher scores indicating greater severity of depression.
Time frame: Baseline and Minute 180, during Study Visits 1 through 5, up to 6 weeks
Population: The MADRS assessment was only given at the baseline time point during the follow-up visit as no medication was administered during this visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Montgomery Asberg Depression Rating Scale (MADRS) Score | Baseline | 18.7 score on a scale | Standard Deviation 6.57 |
| 10 mg Intranasal Ketamine | Montgomery Asberg Depression Rating Scale (MADRS) Score | Minute 180 | 13.5 score on a scale | Standard Deviation 4.38 |
| 10 mg Intravenous (IV) Ketamine | Montgomery Asberg Depression Rating Scale (MADRS) Score | Minute 180 | 13.3 score on a scale | Standard Deviation 5.31 |
| 10 mg Intravenous (IV) Ketamine | Montgomery Asberg Depression Rating Scale (MADRS) Score | Baseline | 13.4 score on a scale | Standard Deviation 6.4 |
| 30 mg Intranasal Ketamine | Montgomery Asberg Depression Rating Scale (MADRS) Score | Minute 180 | 11.3 score on a scale | Standard Deviation 6.15 |
| 30 mg Intranasal Ketamine | Montgomery Asberg Depression Rating Scale (MADRS) Score | Baseline | 12 score on a scale | Standard Deviation 5.05 |
| 50 mg Intranasal Ketamine | Montgomery Asberg Depression Rating Scale (MADRS) Score | Minute 180 | 9.67 score on a scale | Standard Deviation 8.34 |
| 50 mg Intranasal Ketamine | Montgomery Asberg Depression Rating Scale (MADRS) Score | Baseline | 11.89 score on a scale | Standard Deviation 8.34 |
| Follow-up Visit | Montgomery Asberg Depression Rating Scale (MADRS) Score | Baseline | 14.78 score on a scale | Standard Deviation 7.31 |
Primary
Numerical Pain Rating Scale (NPRS) Score
The Numerical Pain Rating Scale (NPRS) was used to evaluate patient reported pain. Pain scores were recorded prior to and at 5,10,15, 30, 45, 60, 120, 180 and 240 minutes after administration of ketamine. The NPRS asks participants rate their current level of pain intensity on a scale from 0 (no pain) to 10 (worst possible pain). In general, improvements of pain severity of 1.5 points or less on NPRS could be seen as clinically irrelevant. Above that value, the cutoff point for clinical relevance depends on patients' baseline pain severity, and ranges from 2.4 to 5.3. Higher baseline scores require larger raw changes to represent clinically important differences.
Time frame: Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, and 240 during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 45 | 5 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 30 | 4.5 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 15 | 5 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 240 | 5 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 180 | 5 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 5 | 6 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Baseline | 7.5 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 120 | 4.5 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 60 | 4.5 units on a scale |
| 10 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 10 | 6 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 10 | 0 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Baseline | 6 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 5 | 1 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 15 | 1.5 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 30 | 2.5 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 45 | 3 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 60 | 3.5 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 120 | 3.5 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 180 | 4 units on a scale |
| 10 mg Intravenous (IV) Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 240 | 3 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 10 | 3 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 45 | 3 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Baseline | 5.5 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 60 | 2.5 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 5 | 5 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 120 | 3 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 240 | 3 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 15 | 3.5 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 180 | 3 units on a scale |
| 30 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 30 | 3.5 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 15 | 3 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 180 | 2.5 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 120 | 2 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 45 | 2 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 5 | 5 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Baseline | 6 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 10 | 4 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 60 | 2 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 30 | 2 units on a scale |
| 50 mg Intranasal Ketamine | Numerical Pain Rating Scale (NPRS) Score | Minute 240 | 5 units on a scale |
Primary
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
The PROMIS Global Health questionnaire, version 1.1, consists of 10 items assessing general domains of health and functioning. Items are scored on a 5-point scale where 1 = poor and 5 = excellent. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better health and functioning, while scores below 50 indicate physical, mental and social health that is below average.
Time frame: Baseline during Visit 1 and Visit 5, up to 6 weeks
Population: One participant did not complete the PROMIS questionnaire at the Follow-up Visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score | Physical T-Score | 35.5 T-score | Standard Deviation 5.7 |
| 10 mg Intranasal Ketamine | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score | Mental T-Score | 43.02 T-score | Standard Deviation 4.17 |
| 10 mg Intravenous (IV) Ketamine | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score | Physical T-Score | 33.96 T-score | Standard Deviation 4.24 |
| 10 mg Intravenous (IV) Ketamine | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score | Mental T-Score | 40.52 T-score | Standard Deviation 7.26 |
Primary
Peak Concentration (Cmax) of Ketamine
Blood samples were obtained at the study visits where ketamine was administered to measure the peak concentration (Cmax) of intranasal and intravenous ketamine. Peak concentration is assessed as the maximum ng/mL of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained at 2, 30, 60 and 240 minutes after medication administration.
Time frame: Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 weeks
Population: This analysis includes participants with viable samples. Some samples were not able to be reliably analyzed for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Intranasal Ketamine | Peak Concentration (Cmax) of Ketamine | 22.9 ng/ml | Standard Deviation 1.97 |
| 10 mg Intravenous (IV) Ketamine | Peak Concentration (Cmax) of Ketamine | 296 ng/ml | Standard Deviation 1.71 |
| 30 mg Intranasal Ketamine | Peak Concentration (Cmax) of Ketamine | 60.8 ng/ml | Standard Deviation 1.9 |
| 50 mg Intranasal Ketamine | Peak Concentration (Cmax) of Ketamine | 77.6 ng/ml | Standard Deviation 2.29 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score
To evaluate self-reported change in hearing, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 240 | 0.3 units on a scale | Standard Deviation 0.95 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 30 | 0.1 units on a scale | Standard Deviation 0.32 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Baseline | 0.1 units on a scale | Standard Deviation 0.32 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score
To evaluate self-reported change in vision, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Baseline | 0.4 units on a scale | Standard Deviation 0.7 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 30 | 0.1 units on a scale | Standard Deviation 0.32 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 30 | 0.5 units on a scale | Standard Deviation 0.85 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 60 | 0.1 units on a scale | Standard Deviation 0.32 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Baseline | 0.1 units on a scale | Standard Deviation 0.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 30 | 0.1 units on a scale | Standard Deviation 0.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Baseline | 0.1 units on a scale | Standard Deviation 0.32 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 30 | 0.1 units on a scale | Standard Deviation 0.21 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score | Minute 60 | 0.1 units on a scale | Standard Deviation 0.32 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score
To evaluate self-reported dizziness, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Baseline | 0.6 units on a scale | Standard Deviation 0.97 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 30 | 0.1 units on a scale | Standard Deviation 0.32 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 30 | 0.8 units on a scale | Standard Deviation 1.14 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 60 | 0.3 units on a scale | Standard Deviation 0.95 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Baseline | 0.1 units on a scale | Standard Deviation 0.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 60 | 0.1 units on a scale | Standard Deviation 0.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 30 | 0.3 units on a scale | Standard Deviation 0.67 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 30 | 0.5 units on a scale | Standard Deviation 0.71 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score | Minute 60 | 0.2 units on a scale | Standard Deviation 0.63 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score
To evaluate self-reported fatigue, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Baseline | 2.9 units on a scale | Standard Deviation 0.86 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 60 | 0.7 units on a scale | Standard Deviation 0.95 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 30 | 1 units on a scale | Standard Deviation 1.15 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 240 | 0.8 units on a scale | Standard Deviation 0.92 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 60 | 1.2 units on a scale | Standard Deviation 1.23 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 240 | 1 units on a scale | Standard Deviation 0.82 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 30 | 1.6 units on a scale | Standard Deviation 1.17 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Baseline | 1.4 units on a scale | Standard Deviation 0.84 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 30 | 1.3 units on a scale | Standard Deviation 1.06 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 60 | 1.2 units on a scale | Standard Deviation 1.14 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Baseline | 1.6 units on a scale | Standard Deviation 0.7 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 240 | 0.8 units on a scale | Standard Deviation 1.03 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 240 | 0.7 units on a scale | Standard Deviation 0.67 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Baseline | 1.5 units on a scale | Standard Deviation 1.27 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 60 | 1.2 units on a scale | Standard Deviation 1.03 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score | Minute 30 | 1.0 units on a scale | Standard Deviation 1.25 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score
To evaluate self-reported feeling of unreality, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Baseline | 0.2 units on a scale | Standard Deviation 0.63 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 30 | 0.4 units on a scale | Standard Deviation 1.26 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 30 | 1.3 units on a scale | Standard Deviation 1.42 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 60 | 0.5 units on a scale | Standard Deviation 1.27 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 240 | 0.2 units on a scale | Standard Deviation 0.63 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 30 | 0.2 units on a scale | Standard Deviation 0.42 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 30 | 0.2 units on a scale | Standard Deviation 0.42 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score | Minute 60 | 0.1 units on a scale | Standard Deviation 0.32 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score
To evaluate self-reported general discomfort, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Baseline | 1.6 units on a scale | Standard Deviation 1.51 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 30 | 0.9 units on a scale | Standard Deviation 1.37 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 60 | 0.6 units on a scale | Standard Deviation 1.35 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 240 | 0.5 units on a scale | Standard Deviation 1.08 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 30 | 1.1 units on a scale | Standard Deviation 1.45 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 60 | 0.8 units on a scale | Standard Deviation 1.32 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 240 | 0.8 units on a scale | Standard Deviation 1.32 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Baseline | 1.3 units on a scale | Standard Deviation 1.34 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 60 | 0.8 units on a scale | Standard Deviation 1.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 30 | 0.8 units on a scale | Standard Deviation 1.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 240 | 0.8 units on a scale | Standard Deviation 1.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Baseline | 1.2 units on a scale | Standard Deviation 1.32 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 240 | 1.2 units on a scale | Standard Deviation 1.62 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 30 | 0.8 units on a scale | Standard Deviation 1.14 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Baseline | 1.1 units on a scale | Standard Deviation 1.45 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) General Discomfort Score | Minute 60 | 0.8 units on a scale | Standard Deviation 1.32 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score
To evaluate self-reported hallucinations, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Hallucinations Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score
To evaluate self-reported headache, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Baseline | 0.2 units on a scale | Standard Deviation 0.63 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 30 | 0.1 units on a scale | Standard Deviation 0.32 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 60 | 0.1 units on a scale | Standard Deviation 0.32 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score
To evaluate self-reported mood change, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 30 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Baseline | 0.5 units on a scale | Standard Deviation 0.85 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 30 | 0.6 units on a scale | Standard Deviation 1.26 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 60 | 0.4 units on a scale | Standard Deviation 1.26 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Baseline | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 60 | 0 units on a scale | Standard Deviation 0 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 30 | 0.1 units on a scale | Standard Deviation 0.32 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 240 | 0.3 units on a scale | Standard Deviation 0.67 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 30 | 0.4 units on a scale | Standard Deviation 0.7 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Minute 60 | 0.1 units on a scale | Standard Deviation 0.32 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Mood Change Score | Baseline | 0.5 units on a scale | Standard Deviation 1.08 |
Primary
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score
To evaluate self-reported nausea, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).
Time frame: Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Baseline | 0.2 units on a scale | Standard Deviation 0.42 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 240 | 0.1 units on a scale | Standard Deviation 0.32 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 30 | 0.3 units on a scale | Standard Deviation 0.95 |
| 10 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 60 | 0.2 units on a scale | Standard Deviation 0.63 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 60 | 0.6 units on a scale | Standard Deviation 1.07 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 240 | 0 units on a scale | Standard Deviation 0 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Baseline | 0.3 units on a scale | Standard Deviation 0.67 |
| 10 mg Intravenous (IV) Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 30 | 0.8 units on a scale | Standard Deviation 1.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 30 | 0.4 units on a scale | Standard Deviation 0.97 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Baseline | 0.1 units on a scale | Standard Deviation 0.32 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 240 | 0.4 units on a scale | Standard Deviation 0.97 |
| 30 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 60 | 0.1 units on a scale | Standard Deviation 0.32 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 240 | 0.4 units on a scale | Standard Deviation 1.26 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Baseline | 0.1 units on a scale | Standard Deviation 0.32 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 30 | 0.3 units on a scale | Standard Deviation 0.67 |
| 50 mg Intranasal Ketamine | Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score | Minute 60 | 0.3 units on a scale | Standard Deviation 0.67 |
Primary
Time to Peak Concentration (Tmax) of Ketamine
Blood samples were obtained at the study visits where ketamine was administered to measure the time to peak concentration (Tmax) of intranasal and intravenous ketamine. Time is measured as minutes after administration when the maximum concentration of ketamine in blood is reached.
Time frame: Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 weeks
Population: This analysis includes participants with viable samples. Some samples were not able to be reliably analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Intranasal Ketamine | Time to Peak Concentration (Tmax) of Ketamine | 23 minutes | Standard Deviation 3 |
| 10 mg Intravenous (IV) Ketamine | Time to Peak Concentration (Tmax) of Ketamine | 2 minutes | Standard Deviation 1 |
| 30 mg Intranasal Ketamine | Time to Peak Concentration (Tmax) of Ketamine | 14 minutes | Standard Deviation 3.8 |
| 50 mg Intranasal Ketamine | Time to Peak Concentration (Tmax) of Ketamine | 16 minutes | Standard Deviation 4.4 |
Secondary
Frequency of Rescue Medication Use
The opioid sparing effect of NAS ketamine will be determined by evaluating frequency of rescue medications use prior to and during the study.
Time frame: Visit 1 through Visit 5, up to 6 weeks
Population: Due to inconsistencies with participant-reported pill counts, the data for rescue medication use could not be reliably analyzed.
Secondary
Total Opioid Consumption
The opioid sparing effect of NAS ketamine will be determined by evaluating total opioid consumption (rescue medication) prior to and during the study.
Time frame: Visit 1 through Visit 5, up to 6 weeks
Population: Due to inconsistencies with participant-reported pill counts, the data for total opioid consumption use could not be reliably analyzed.
Post Hoc
Diastolic Blood Pressure
Blood pressure was measured at Baseline and up to 240 minutes after administration of ketamine.
Time frame: Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 10 | 76.6 mmHg | Standard Deviation 7.9 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 120 | 72.9 mmHg | Standard Deviation 8.9 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 45 | 74.8 mmHg | Standard Deviation 7.4 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 5 | 73.0 mmHg | Standard Deviation 9.1 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 15 | 73.4 mmHg | Standard Deviation 6.8 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 240 | 73.3 mmHg | Standard Deviation 7.32 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 30 | 74.3 mmHg | Standard Deviation 6.7 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 180 | 69.1 mmHg | Standard Deviation 11.1 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 60 | 73.0 mmHg | Standard Deviation 7.3 |
| 10 mg Intranasal Ketamine | Diastolic Blood Pressure | Baseline | 72.5 mmHg | Standard Deviation 7.2 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 120 | 72.9 mmHg | Standard Deviation 7.3 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 5 | 82.4 mmHg | Standard Deviation 11 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 180 | 71.9 mmHg | Standard Deviation 6.1 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 240 | 70.2 mmHg | Standard Deviation 5.5 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 10 | 81.1 mmHg | Standard Deviation 6.4 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Baseline | 76.3 mmHg | Standard Deviation 10.7 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 15 | 78.5 mmHg | Standard Deviation 6.3 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 30 | 72.2 mmHg | Standard Deviation 8.1 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 45 | 71.7 mmHg | Standard Deviation 12.3 |
| 10 mg Intravenous (IV) Ketamine | Diastolic Blood Pressure | Minute 60 | 73.6 mmHg | Standard Deviation 6.3 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 10 | 75.2 mmHg | Standard Deviation 9.8 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 180 | 69.0 mmHg | Standard Deviation 6.5 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 45 | 75.5 mmHg | Standard Deviation 10.8 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 15 | 74.1 mmHg | Standard Deviation 10.6 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 240 | 72.7 mmHg | Standard Deviation 6.4 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 120 | 72.1 mmHg | Standard Deviation 7.5 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 60 | 75.4 mmHg | Standard Deviation 11.3 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 5 | 72.1 mmHg | Standard Deviation 9.4 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 30 | 75.9 mmHg | Standard Deviation 11.2 |
| 30 mg Intranasal Ketamine | Diastolic Blood Pressure | Baseline | 73.5 mmHg | Standard Deviation 9.8 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 240 | 75.3 mmHg | Standard Deviation 11.9 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Baseline | 72.2 mmHg | Standard Deviation 9 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 5 | 74.4 mmHg | Standard Deviation 10.1 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 10 | 73.2 mmHg | Standard Deviation 11.8 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 30 | 77.1 mmHg | Standard Deviation 8.6 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 45 | 73.4 mmHg | Standard Deviation 8.8 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 60 | 73.4 mmHg | Standard Deviation 10.5 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 120 | 72.2 mmHg | Standard Deviation 8.1 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 180 | 70.8 mmHg | Standard Deviation 10 |
| 50 mg Intranasal Ketamine | Diastolic Blood Pressure | Minute 15 | 76.8 mmHg | Standard Deviation 8.3 |
Post Hoc
Heart Rate
Heart rate was measured at Baseline and up to 240 minutes after administration of ketamine.
Time frame: Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Heart Rate | Minute 240 | 80.9 beats per minute | Standard Deviation 21.6 |
| 10 mg Intranasal Ketamine | Heart Rate | Minute 120 | 81.6 beats per minute | Standard Deviation 18.7 |
| 10 mg Intranasal Ketamine | Heart Rate | Minute 45 | 78.7 beats per minute | Standard Deviation 17.7 |
| 10 mg Intranasal Ketamine | Heart Rate | Minute 5 | 80.4 beats per minute | Standard Deviation 19.6 |
| 10 mg Intranasal Ketamine | Heart Rate | Minute 60 | 75.9 beats per minute | Standard Deviation 16.5 |
| 10 mg Intranasal Ketamine | Heart Rate | Baseline | 80.0 beats per minute | Standard Deviation 19.6 |
| 10 mg Intranasal Ketamine | Heart Rate | Minute 10 | 78.9 beats per minute | Standard Deviation 17 |
| 10 mg Intranasal Ketamine | Heart Rate | Minute 180 | 79.1 beats per minute | Standard Deviation 20.4 |
| 10 mg Intranasal Ketamine | Heart Rate | Minute 15 | 77.3 beats per minute | Standard Deviation 15.4 |
| 10 mg Intranasal Ketamine | Heart Rate | Minute 30 | 79.1 beats per minute | Standard Deviation 17.2 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 240 | 80.2 beats per minute | Standard Deviation 17.8 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 10 | 81.1 beats per minute | Standard Deviation 15.2 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Baseline | 82.2 beats per minute | Standard Deviation 18.4 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 45 | 73.2 beats per minute | Standard Deviation 17.5 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 120 | 78.5 beats per minute | Standard Deviation 17.9 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 60 | 74.4 beats per minute | Standard Deviation 14.2 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 30 | 75.3 beats per minute | Standard Deviation 13.2 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 5 | 84.3 beats per minute | Standard Deviation 18.2 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 15 | 78.4 beats per minute | Standard Deviation 16.2 |
| 10 mg Intravenous (IV) Ketamine | Heart Rate | Minute 180 | 76.7 beats per minute | Standard Deviation 15.6 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 30 | 74.2 beats per minute | Standard Deviation 12 |
| 30 mg Intranasal Ketamine | Heart Rate | Baseline | 81.3 beats per minute | Standard Deviation 16 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 5 | 76.7 beats per minute | Standard Deviation 14.2 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 10 | 75.7 beats per minute | Standard Deviation 12.7 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 15 | 76.6 beats per minute | Standard Deviation 13 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 240 | 74.0 beats per minute | Standard Deviation 13.6 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 45 | 75.2 beats per minute | Standard Deviation 12 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 60 | 75.8 beats per minute | Standard Deviation 13.6 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 120 | 76.1 beats per minute | Standard Deviation 16.2 |
| 30 mg Intranasal Ketamine | Heart Rate | Minute 180 | 78.0 beats per minute | Standard Deviation 16.7 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 30 | 81.2 beats per minute | Standard Deviation 16.4 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 15 | 81.6 beats per minute | Standard Deviation 15.5 |
| 50 mg Intranasal Ketamine | Heart Rate | Baseline | 79.5 beats per minute | Standard Deviation 14.6 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 120 | 78.9 beats per minute | Standard Deviation 15.9 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 10 | 79.7 beats per minute | Standard Deviation 14.5 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 5 | 79.9 beats per minute | Standard Deviation 13.6 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 240 | 79.8 beats per minute | Standard Deviation 14.2 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 45 | 79.7 beats per minute | Standard Deviation 15 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 180 | 80.0 beats per minute | Standard Deviation 16 |
| 50 mg Intranasal Ketamine | Heart Rate | Minute 60 | 80.3 beats per minute | Standard Deviation 16 |
Post Hoc
Systolic Blood Pressure
Blood pressure was measured at Baseline and up to 240 minutes after administration of ketamine.
Time frame: Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, 240, during Study Visits 1 through 4, up to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 180 | 111.9 millimeters of mercury (mmHg) | Standard Deviation 24.7 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 5 | 117.8 millimeters of mercury (mmHg) | Standard Deviation 19.2 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 120 | 117.2 millimeters of mercury (mmHg) | Standard Deviation 18.9 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 10 | 122.3 millimeters of mercury (mmHg) | Standard Deviation 19 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Baseline | 118.6 millimeters of mercury (mmHg) | Standard Deviation 19.7 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 60 | 116.9 millimeters of mercury (mmHg) | Standard Deviation 19.4 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 15 | 119.0 millimeters of mercury (mmHg) | Standard Deviation 23 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 45 | 119.8 millimeters of mercury (mmHg) | Standard Deviation 22.3 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 240 | 116.2 millimeters of mercury (mmHg) | Standard Deviation 23.4 |
| 10 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 30 | 121.7 millimeters of mercury (mmHg) | Standard Deviation 22 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 240 | 111.7 millimeters of mercury (mmHg) | Standard Deviation 12.9 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 30 | 117.2 millimeters of mercury (mmHg) | Standard Deviation 20.6 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 45 | 117.4 millimeters of mercury (mmHg) | Standard Deviation 15.1 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 180 | 115.9 millimeters of mercury (mmHg) | Standard Deviation 15.5 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 60 | 114.1 millimeters of mercury (mmHg) | Standard Deviation 13.4 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 120 | 111.5 millimeters of mercury (mmHg) | Standard Deviation 13.4 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 5 | 134.4 millimeters of mercury (mmHg) | Standard Deviation 30.7 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 10 | 129.6 millimeters of mercury (mmHg) | Standard Deviation 23.3 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Baseline | 117.5 millimeters of mercury (mmHg) | Standard Deviation 20.8 |
| 10 mg Intravenous (IV) Ketamine | Systolic Blood Pressure | Minute 15 | 124.0 millimeters of mercury (mmHg) | Standard Deviation 20.9 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 120 | 114.9 millimeters of mercury (mmHg) | Standard Deviation 17.8 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 180 | 116.3 millimeters of mercury (mmHg) | Standard Deviation 19.3 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 240 | 118.2 millimeters of mercury (mmHg) | Standard Deviation 19.4 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Baseline | 117.6 millimeters of mercury (mmHg) | Standard Deviation 20 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 10 | 122.9 millimeters of mercury (mmHg) | Standard Deviation 20.2 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 60 | 118.7 millimeters of mercury (mmHg) | Standard Deviation 20.8 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 15 | 123.1 millimeters of mercury (mmHg) | Standard Deviation 25 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 5 | 119.9 millimeters of mercury (mmHg) | Standard Deviation 20 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 30 | 125.4 millimeters of mercury (mmHg) | Standard Deviation 23 |
| 30 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 45 | 121.3 millimeters of mercury (mmHg) | Standard Deviation 18.5 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 240 | 116.5 millimeters of mercury (mmHg) | Standard Deviation 23.9 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 5 | 118.3 millimeters of mercury (mmHg) | Standard Deviation 14.8 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Baseline | 115.8 millimeters of mercury (mmHg) | Standard Deviation 19.3 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 10 | 120.2 millimeters of mercury (mmHg) | Standard Deviation 19.1 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 15 | 123.1 millimeters of mercury (mmHg) | Standard Deviation 16.9 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 30 | 124.9 millimeters of mercury (mmHg) | Standard Deviation 18.1 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 45 | 117.0 millimeters of mercury (mmHg) | Standard Deviation 18.4 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 120 | 111.5 millimeters of mercury (mmHg) | Standard Deviation 13 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 180 | 111.7 millimeters of mercury (mmHg) | Standard Deviation 13.2 |
| 50 mg Intranasal Ketamine | Systolic Blood Pressure | Minute 60 | 118.6 millimeters of mercury (mmHg) | Standard Deviation 17.4 |