Acute Pain
Conditions
Brief summary
Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
Detailed description
Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups. Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.
Interventions
DRUGKetamine
Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.
Intervention model description
The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults ages 18-59 * Weight 45 - 115 kg * Acute abdominal, flank, back, musculoskeletal pain, or a headache * Onset of pain within 7 days * Pain score of 5 or more * Requiring intravenous analgesia * Hasn't been enrolled in this study previously
Exclusion criteria
* Pregnancy * Breast-feeding * Altered mental status rendering the patient unable to consent to the study * Allergy to ketamine * Unstable vital signs (systolic blood pressure \<90 or \>180 mm Hg, pulse rate \<50 or \>150 beats/minute, and respiration rate \<10 or \>30 breaths/minute) * History of acute head or eye injury, seizure, intracranial hypertension * Chronic pain * Renal or hepatic insufficiency * Known alcohol or drug use disorder * Currently under influence of alcohol/opiates * Acute psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration | 30 minutes | Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score From Baseline to 15 Minutes | 15 minutes | Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain. |
| Change in Pain Score From Baseline to 60 Minutes | 60 minutes | Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain. |
| Number of Participants Who Need Additional Pain Medication at 30 Minutes | 30 minutes | Patient request for additional pain medications at 30 minutes post initiation of drug administration |
| Number of Patients Who Need Rescue Medications at 60 Minutes | 60 minutes | Patient request for additional pain medications at 60 minutes |
| Adverse Effects at 30 Min | 30 minutes | Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.15 mg/kg IV Ketamine Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes | 49 |
| 0.3 mg/kg IV Ketamine Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes | 49 |
| Total | 98 |
Baseline characteristics
| Characteristic | 0.3 mg/kg IV Ketamine | Total | 0.15 mg/kg IV Ketamine |
|---|---|---|---|
| Age, Continuous | 37 years | 38 years | 39 years |
| Co-morbidities Anxiety | 7 participants | 8 participants | 1 participants |
| Co-morbidities Cancer | 1 participants | 2 participants | 1 participants |
| Co-morbidities Depression | 10 participants | 13 participants | 3 participants |
| Co-morbidities Diabetes | 3 participants | 16 participants | 13 participants |
| Co-morbidities Heart Failure | 1 participants | 3 participants | 2 participants |
| Co-morbidities Hypertension | 8 participants | 21 participants | 13 participants |
| Co-morbidities Obesity | 9 participants | 20 participants | 11 participants |
| Duration of Pain <24 hours | 28 Participants | 49 Participants | 21 Participants |
| Duration of Pain 2 days | 9 Participants | 18 Participants | 9 Participants |
| Duration of Pain 3-7 days | 12 Participants | 31 Participants | 19 Participants |
| Race/Ethnicity, Customized Race African American | 13 Participants | 28 Participants | 15 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants | 24 Participants | 16 Participants |
| Race/Ethnicity, Customized Race White | 28 Participants | 46 Participants | 18 Participants |
| Region of Enrollment United States | 49 Participants | 98 Participants | 49 Participants |
| Sex: Female, Male Female | 27 Participants | 57 Participants | 30 Participants |
| Sex: Female, Male Male | 22 Participants | 41 Participants | 19 Participants |
| Type of Pain Abdominal | 23 Participants | 46 Participants | 23 Participants |
| Type of Pain Back | 2 Participants | 6 Participants | 4 Participants |
| Type of Pain Flank | 4 Participants | 10 Participants | 6 Participants |
| Type of Pain Headache | 4 Participants | 6 Participants | 2 Participants |
| Type of Pain Musculoskeletal | 16 Participants | 30 Participants | 14 Participants |
| Weight | 84 kilograms | 84 kilograms | 85 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 28 / 49 | 31 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 0.15 mg/kg IV Ketamine | Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration | 3.8 score on a scale |
| 0.3 mg/kg IV Ketamine | Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration | 3.5 score on a scale |
Secondary
Adverse Effects at 30 Min
Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.
Time frame: 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Dizziness | 21 participants |
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Vision Changes | 4 participants |
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Feeling of Unreality | 8 participants |
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Mood Alteration | 4 participants |
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Headache | 16 participants |
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Discomfort | 15 participants |
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Hearing Changes | 0 participants |
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Hallucinations | 2 participants |
| 0.15 mg/kg IV Ketamine | Adverse Effects at 30 Min | Fatigue | 18 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Hallucinations | 3 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Fatigue | 20 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Dizziness | 16 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Headache | 11 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Feeling of Unreality | 6 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Hearing Changes | 2 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Vision Changes | 6 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Mood Alteration | 6 participants |
| 0.3 mg/kg IV Ketamine | Adverse Effects at 30 Min | Discomfort | 21 participants |
Secondary
Change in Pain Score From Baseline to 15 Minutes
Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 0.15 mg/kg IV Ketamine | Change in Pain Score From Baseline to 15 Minutes | 3.6 score on a scale |
| 0.3 mg/kg IV Ketamine | Change in Pain Score From Baseline to 15 Minutes | 4.8 score on a scale |
Secondary
Change in Pain Score From Baseline to 60 Minutes
Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 0.15 mg/kg IV Ketamine | Change in Pain Score From Baseline to 60 Minutes | 3.7 score on a scale |
| 0.3 mg/kg IV Ketamine | Change in Pain Score From Baseline to 60 Minutes | 3.5 score on a scale |
Secondary
Number of Participants Who Need Additional Pain Medication at 30 Minutes
Patient request for additional pain medications at 30 minutes post initiation of drug administration
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.15 mg/kg IV Ketamine | Number of Participants Who Need Additional Pain Medication at 30 Minutes | 1 Participants |
| 0.3 mg/kg IV Ketamine | Number of Participants Who Need Additional Pain Medication at 30 Minutes | 0 Participants |
Secondary
Number of Patients Who Need Rescue Medications at 60 Minutes
Patient request for additional pain medications at 60 minutes
Time frame: 60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.15 mg/kg IV Ketamine | Number of Patients Who Need Rescue Medications at 60 Minutes | 2 Participants |
| 0.3 mg/kg IV Ketamine | Number of Patients Who Need Rescue Medications at 60 Minutes | 4 Participants |