Sub-dissociative Dose Ketamine Dosing Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.15 mg/kg IV Ketamine<br> | Drug: Ketamine<br>* Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes<br>|
| Active Comparator: 0.3 mg/kg IV Ketamine<br> | Drug: Ketamine<br>* Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 minutes | 
| 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. | 60 minutes | 
| 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 | 30 minutes | 
| Number of Patients Who Need Rescue Medications at 60 Minutes | Patient request for additional pain medications at 60 minutes | 60 minutes | 
| Adverse Effects at 30 Min | Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc. | 30 minutes |