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

• Status: Withdrawn
• Trial end date: 2020-02-05
• Target enrollment: 0
• Participant gender: All

Summary

In this proposal, the investigators will determine if a single dose of intravenous (IV) ketamine (in combination with midazolam) reduces pain severity, depressive symptoms and need for opiate analgesics both in the ED and in the acute recovery period after ED discharge. The investigators will compare the ketamine arm to an active placebo-controlled arm (with midazolam).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Pacella
• Collaborators: University of Pittsburgh Physicians; University of Pittsburgh Physicians (UPP)/UPMC Academic Foundation
• Treatments: Ketamine; Midazolam

Criteria

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