Single-dose Ketamine for the Reduction of Pain... — Clinical Trial Details

This parallel-group, randomised, quadruple-blind study will compare a single IV ketamine infusion (0.3 mg/kg) co-administered with midazolam to placebo plus midazolam in medically stable adults presenting to emergency departments with acute pain.

Outcomes include repeated measures of pain and mood in the ED (every 30 minutes), recording of analgesics given, and follow-up assessments of pain, mood, and analgesic use at 7 and 14 days post-discharge.

Inclusion Criteria:
1. Adults between the ages of 18-65
2. A chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale [NRS] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable")
3. Expected to be in the ED for at least 2 hours

Exclusion Criteria:
1. Non-English speaking
2. Not medically suitable for ketamine per treating MD (e.g. medical condition where ketamine is contraindicated; ketamine or midazolam may be unsafe, e.g., known sensitivity, glaucoma, or other concerns)
3. Not alert and oriented
4. Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
5. Seeking treatment due to a mental health or substance use disorder
6. History of chronic opioid use
7. Prescribed opioid use within the past 24 hours
8. Any use of recreational narcotics throughout lifetime
9. Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
10. Weight > 170kg (375 lbs)
11. Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
12. Pregnancy
13. Prisoner

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Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine + midazolam

Interventions

Placebo + midazolam

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details