Otolaryngeal Cancer
Conditions
Keywords
Anesthesiology
Brief summary
The goal of this prospective randomized double blinded placebo controlled study is to investigate if a single dose of ketamine in addition to standard anesthesia will reduce the risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will be utilized during the surgical procedure to evaluate its potential as a possible predictive device for delirium.
Detailed description
This is a single center prospective randomized double blinded placebo controlled study. The primary aim of the study is to optimize the intraoperative treatment protocol for head and neck cancer patients to reduce the incidence of delirium and associated postoperative cognitive dysfunction. Secondary aims are to determine the dose response relationship for intraoperative ketamine and delirium reduction, determine if a single dose of ketamine will reduce post-operative pain and opioid requirements, determine if raw electroencephalogram (EEG) data can predict postoperative delirium during general anesthesia, and to evaluate length of intensive care unit (ICU) and length of hospital stay. Participants will be randomized to one of three groups after administration of general anesthesia; one dose of .5 mg/kg intravenous (IV) Ketamine, 1.0 mg/kg of IV Ketamine, or IV placebo. An EEG will be used during the surgical procedure to gather raw data for off line analysis among patients developing post-operative delirium.
Interventions
DRUGKetamine
Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
DRUGPlacebo
Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current diagnosis of otolaryngeal cancer and undergoing surgery with general anesthesia * Competent to provide informed consent
Exclusion criteria
* Emergency surgery * Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general anesthesia) * Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement * Poor health literacy * Allergy, or have experienced any drug reaction to ketamine * Pregnant or lactating * Currently in active alcohol withdrawal * Taking buprenorphine for chronic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours) | The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as present. Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioral Pain Scale (Non-Intubated) Score | Post Operation (Up to 6 Hours), Post Operation Day 0 | The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain). |
| Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks) | Scores range from 0 (no pain) to 10 (worst pain). |
| Change in Mini Cog Score | Baseline, Post Surgery (Up to 6 Weeks) | The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia. |
| Change in Mini-Mental Status Examination (MMSE) Score | Baseline, Post Surgery (Up to 6 Weeks) | The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment. |
| Change in Cognitive Failure Questionnaire (CFQ) Score | Baseline, Post Surgery (Up to 6 Weeks) | The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention. |
| Post Operative Narcotics Use | Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention) | The total amount of narcotics used measured in morphine milligram equivalents (MME). |
| Associations of Intraoperative EEG Patterns With PACU Delirium | Intraoperative EEG and delirium during PACU stay | The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine 0.5 mg/kg Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.
Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | 21 |
| Ketamine 1.0 mg/kg Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.
Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | 26 |
| Placebo Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.
Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | 24 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Ketamine 0.5 mg/kg | Total | Placebo | Ketamine 1.0 mg/kg |
|---|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 8.6 | 64.3 years STANDARD_DEVIATION 10.9 | 64.5 years STANDARD_DEVIATION 11.5 | 64.6 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 70 Participants | 24 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 10 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 59 Participants | 20 Participants | 21 Participants |
| Region of Enrollment United States | 21 participants | 71 participants | 24 participants | 26 participants |
| Sex: Female, Male Female | 9 Participants | 25 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Male | 12 Participants | 46 Participants | 16 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 1 / 26 | 0 / 24 |
| other Total, other adverse events | 3 / 21 | 5 / 26 | 4 / 24 |
| serious Total, serious adverse events | 4 / 21 | 9 / 26 | 2 / 24 |
Outcome results
Primary
Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score
The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as present. Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.
Time frame: Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)
Population: Unable to collect data in 15 participants. N=12: Provider not available. N=2 No PACU. N=1 Physician Decision (withdrawal)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine 0.5 mg/kg | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | Delirium CAM-ICU Score at PACU Arrival | 11 Participants |
| Ketamine 0.5 mg/kg | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | No Delirium CAM-ICU Score at PACU Arrival | 6 Participants |
| Ketamine 0.5 mg/kg | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | Delirium CAM-ICU Score at PACU Discharge | 6 Participants |
| Ketamine 0.5 mg/kg | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | No Delirium CAM-ICU Score at PACU Discharge | 11 Participants |
| Ketamine 1.0 mg/kg | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | No Delirium CAM-ICU Score at PACU Discharge | 17 Participants |
| Ketamine 1.0 mg/kg | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | Delirium CAM-ICU Score at PACU Arrival | 9 Participants |
| Ketamine 1.0 mg/kg | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | Delirium CAM-ICU Score at PACU Discharge | 5 Participants |
| Ketamine 1.0 mg/kg | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | No Delirium CAM-ICU Score at PACU Arrival | 13 Participants |
| Placebo | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | No Delirium CAM-ICU Score at PACU Discharge | 15 Participants |
| Placebo | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | No Delirium CAM-ICU Score at PACU Arrival | 10 Participants |
| Placebo | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | Delirium CAM-ICU Score at PACU Discharge | 2 Participants |
| Placebo | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | Delirium CAM-ICU Score at PACU Arrival | 9 Participants |
Secondary
Associations of Intraoperative EEG Patterns With PACU Delirium
The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown.
Time frame: Intraoperative EEG and delirium during PACU stay
Population: Only a total of 38 EEGs with sufficient quality were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine 0.5 mg/kg | Associations of Intraoperative EEG Patterns With PACU Delirium | Positive Delirium for PACU | 10.0 Percentage of cumulative power | Standard Deviation 5 |
| Ketamine 0.5 mg/kg | Associations of Intraoperative EEG Patterns With PACU Delirium | Negative Delirium for PACU | 7.0 Percentage of cumulative power | Standard Deviation 1 |
| Ketamine 1.0 mg/kg | Associations of Intraoperative EEG Patterns With PACU Delirium | Positive Delirium for PACU | 7.0 Percentage of cumulative power | Standard Deviation 5 |
| Ketamine 1.0 mg/kg | Associations of Intraoperative EEG Patterns With PACU Delirium | Negative Delirium for PACU | 5.0 Percentage of cumulative power | Standard Deviation 6 |
| Placebo | Associations of Intraoperative EEG Patterns With PACU Delirium | Positive Delirium for PACU | 7.0 Percentage of cumulative power | Standard Deviation 6 |
| Placebo | Associations of Intraoperative EEG Patterns With PACU Delirium | Negative Delirium for PACU | 6.0 Percentage of cumulative power | Standard Deviation 4 |
Secondary
Change in Behavioral Pain Scale (Non-Intubated) Score
The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).
Time frame: Post Operation (Up to 6 Hours), Post Operation Day 0
Population: Unable to collect information for this outcome. The investigators collected the pain scales from the EMR. The BPS was not routinely collected in the hospital and they only report Visual analog scale (VAS).
Secondary
Change in Cognitive Failure Questionnaire (CFQ) Score
The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention.
Time frame: Baseline, Post Surgery (Up to 6 Weeks)
Population: This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ketamine 0.5 mg/kg | Change in Cognitive Failure Questionnaire (CFQ) Score | Baseline CFQ Score | 27 score on a scale |
| Ketamine 0.5 mg/kg | Change in Cognitive Failure Questionnaire (CFQ) Score | CFQ Score Post surgery (Up to 6 weeks) | 29 score on a scale |
| Ketamine 1.0 mg/kg | Change in Cognitive Failure Questionnaire (CFQ) Score | Baseline CFQ Score | 34 score on a scale |
| Ketamine 1.0 mg/kg | Change in Cognitive Failure Questionnaire (CFQ) Score | CFQ Score Post surgery (Up to 6 weeks) | 30 score on a scale |
| Placebo | Change in Cognitive Failure Questionnaire (CFQ) Score | Baseline CFQ Score | 30 score on a scale |
| Placebo | Change in Cognitive Failure Questionnaire (CFQ) Score | CFQ Score Post surgery (Up to 6 weeks) | 29 score on a scale |
Secondary
Change in Mini Cog Score
The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia.
Time frame: Baseline, Post Surgery (Up to 6 Weeks)
Population: The number of participants is different from participant flow because some of the subjects did not complete the assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine 0.5 mg/kg | Change in Mini Cog Score | Baseline Mini Cog Score- Positive Screen | 2 Participants |
| Ketamine 0.5 mg/kg | Change in Mini Cog Score | Baseline Mini Cog Score- Negative Screen | 18 Participants |
| Ketamine 0.5 mg/kg | Change in Mini Cog Score | Mini Cog Score Post surgery (Up to 6 weeks) - Positive Screen | 3 Participants |
| Ketamine 0.5 mg/kg | Change in Mini Cog Score | Mini Cog Score Post surgery (Up to 6 weeks) - Negative Screen | 17 Participants |
| Ketamine 1.0 mg/kg | Change in Mini Cog Score | Mini Cog Score Post surgery (Up to 6 weeks) - Negative Screen | 23 Participants |
| Ketamine 1.0 mg/kg | Change in Mini Cog Score | Baseline Mini Cog Score- Positive Screen | 5 Participants |
| Ketamine 1.0 mg/kg | Change in Mini Cog Score | Mini Cog Score Post surgery (Up to 6 weeks) - Positive Screen | 0 Participants |
| Ketamine 1.0 mg/kg | Change in Mini Cog Score | Baseline Mini Cog Score- Negative Screen | 20 Participants |
| Placebo | Change in Mini Cog Score | Mini Cog Score Post surgery (Up to 6 weeks) - Negative Screen | 17 Participants |
| Placebo | Change in Mini Cog Score | Baseline Mini Cog Score- Negative Screen | 18 Participants |
| Placebo | Change in Mini Cog Score | Mini Cog Score Post surgery (Up to 6 weeks) - Positive Screen | 3 Participants |
| Placebo | Change in Mini Cog Score | Baseline Mini Cog Score- Positive Screen | 6 Participants |
Secondary
Change in Mini-Mental Status Examination (MMSE) Score
The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment.
Time frame: Baseline, Post Surgery (Up to 6 Weeks)
Population: This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine 0.5 mg/kg | Change in Mini-Mental Status Examination (MMSE) Score | Normal Baseline MMSE Score (25-30) | 18 Participants |
| Ketamine 0.5 mg/kg | Change in Mini-Mental Status Examination (MMSE) Score | Cognitive Impairment Baseline MMSE Score (0-24) | 2 Participants |
| Ketamine 0.5 mg/kg | Change in Mini-Mental Status Examination (MMSE) Score | Normal Post surgery (Up to 6 weeks) MMSE Score (25-30) | 17 Participants |
| Ketamine 0.5 mg/kg | Change in Mini-Mental Status Examination (MMSE) Score | Cognitive Impairment Post surgery (Up to 6 weeks) MMSE Score (0-24) | 3 Participants |
| Ketamine 1.0 mg/kg | Change in Mini-Mental Status Examination (MMSE) Score | Cognitive Impairment Post surgery (Up to 6 weeks) MMSE Score (0-24) | 0 Participants |
| Ketamine 1.0 mg/kg | Change in Mini-Mental Status Examination (MMSE) Score | Normal Baseline MMSE Score (25-30) | 22 Participants |
| Ketamine 1.0 mg/kg | Change in Mini-Mental Status Examination (MMSE) Score | Normal Post surgery (Up to 6 weeks) MMSE Score (25-30) | 23 Participants |
| Ketamine 1.0 mg/kg | Change in Mini-Mental Status Examination (MMSE) Score | Cognitive Impairment Baseline MMSE Score (0-24) | 3 Participants |
| Placebo | Change in Mini-Mental Status Examination (MMSE) Score | Cognitive Impairment Post surgery (Up to 6 weeks) MMSE Score (0-24) | 4 Participants |
| Placebo | Change in Mini-Mental Status Examination (MMSE) Score | Cognitive Impairment Baseline MMSE Score (0-24) | 2 Participants |
| Placebo | Change in Mini-Mental Status Examination (MMSE) Score | Normal Post surgery (Up to 6 weeks) MMSE Score (25-30) | 16 Participants |
| Placebo | Change in Mini-Mental Status Examination (MMSE) Score | Normal Baseline MMSE Score (25-30) | 22 Participants |
Secondary
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score
Scores range from 0 (no pain) to 10 (worst pain).
Time frame: Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine 0.5 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (PACU) | 1.00 units on a scale | Standard Deviation 2.45 |
| Ketamine 0.5 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 2) | 2.47 units on a scale | Standard Deviation 2.52 |
| Ketamine 0.5 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 1) | 3.93 units on a scale | Standard Deviation 2.76 |
| Ketamine 0.5 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Baseline Pain Level assessed by the Visual Analog Scale (VAS) Score | 3.50 units on a scale | Standard Deviation 3.25 |
| Ketamine 0.5 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale Score Post surgery (follow up visit - Up to 6 weeks) | 2.3 units on a scale | Standard Deviation 2.58 |
| Ketamine 0.5 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 3) | 3.08 units on a scale | Standard Deviation 2.94 |
| Ketamine 0.5 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 0) | 4.76 units on a scale | Standard Deviation 3.86 |
| Ketamine 1.0 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 1) | 3.72 units on a scale | Standard Deviation 2.55 |
| Ketamine 1.0 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Baseline Pain Level assessed by the Visual Analog Scale (VAS) Score | 4.36 units on a scale | Standard Deviation 2.94 |
| Ketamine 1.0 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (PACU) | 2.56 units on a scale | Standard Deviation 3.28 |
| Ketamine 1.0 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 0) | 4.22 units on a scale | Standard Deviation 3.24 |
| Ketamine 1.0 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 2) | 2.81 units on a scale | Standard Deviation 2.51 |
| Ketamine 1.0 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 3) | 3.35 units on a scale | Standard Deviation 2.15 |
| Ketamine 1.0 mg/kg | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale Score Post surgery (follow up visit - Up to 6 weeks) | 3.09 units on a scale | Standard Deviation 2.68 |
| Placebo | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 2) | 3.38 units on a scale | Standard Deviation 2.62 |
| Placebo | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (PACU) | 1.63 units on a scale | Standard Deviation 3.11 |
| Placebo | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale Score Post surgery (follow up visit - Up to 6 weeks) | 3.00 units on a scale | Standard Deviation 2.6 |
| Placebo | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 3) | 3.41 units on a scale | Standard Deviation 2.2 |
| Placebo | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 1) | 3.52 units on a scale | Standard Deviation 2.42 |
| Placebo | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 0) | 3.62 units on a scale | Standard Deviation 3.74 |
| Placebo | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Baseline Pain Level assessed by the Visual Analog Scale (VAS) Score | 2.30 units on a scale | Standard Deviation 2.88 |
Secondary
Post Operative Narcotics Use
The total amount of narcotics used measured in morphine milligram equivalents (MME).
Time frame: Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention)
Population: The population is different at 6 weeks post intervention because this outcome was not completed for some participants at that time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ketamine 0.5 mg/kg | Post Operative Narcotics Use | Post Intervention (POD 3) | 19.8 morphine milligram equivalents (MME) |
| Ketamine 0.5 mg/kg | Post Operative Narcotics Use | Post Intervention (Follow up visit-up to 6 weeks) | 0 morphine milligram equivalents (MME) |
| Ketamine 0.5 mg/kg | Post Operative Narcotics Use | Post Intervention (POD 2) | 8.59 morphine milligram equivalents (MME) |
| Ketamine 0.5 mg/kg | Post Operative Narcotics Use | Post Intervention (POD 1) | 35 morphine milligram equivalents (MME) |
| Ketamine 0.5 mg/kg | Post Operative Narcotics Use | Post Intervention (Intraoperative) | 13.3 morphine milligram equivalents (MME) |
| Ketamine 0.5 mg/kg | Post Operative Narcotics Use | Post Intervention (POD 0) | 7.1 morphine milligram equivalents (MME) |
| Ketamine 1.0 mg/kg | Post Operative Narcotics Use | Post Intervention (Intraoperative) | 13.3 morphine milligram equivalents (MME) |
| Ketamine 1.0 mg/kg | Post Operative Narcotics Use | Post Intervention (POD 3) | 34.3 morphine milligram equivalents (MME) |
| Ketamine 1.0 mg/kg | Post Operative Narcotics Use | Post Intervention (POD 0) | 6.67 morphine milligram equivalents (MME) |
| Ketamine 1.0 mg/kg | Post Operative Narcotics Use | Post Intervention (POD 2) | 25.7 morphine milligram equivalents (MME) |
| Ketamine 1.0 mg/kg | Post Operative Narcotics Use | Post Intervention (Follow up visit-up to 6 weeks) | 0 morphine milligram equivalents (MME) |
| Ketamine 1.0 mg/kg | Post Operative Narcotics Use | Post Intervention (POD 1) | 41.5 morphine milligram equivalents (MME) |
| Placebo | Post Operative Narcotics Use | Post Intervention (Follow up visit-up to 6 weeks) | 0 morphine milligram equivalents (MME) |
| Placebo | Post Operative Narcotics Use | Post Intervention (Intraoperative) | 13.33 morphine milligram equivalents (MME) |
| Placebo | Post Operative Narcotics Use | Post Intervention (POD 0) | 6.18 morphine milligram equivalents (MME) |
| Placebo | Post Operative Narcotics Use | Post Intervention (POD 1) | 42.9 morphine milligram equivalents (MME) |
| Placebo | Post Operative Narcotics Use | Post Intervention (POD 2) | 41.9 morphine milligram equivalents (MME) |
| Placebo | Post Operative Narcotics Use | Post Intervention (POD 3) | 34.3 morphine milligram equivalents (MME) |