WithdrawnPhase 2 / Phase 3

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

NCT03436121 · Maria Pacella

Closed to entry

Status

Not accepting participants

Phase 2 / Phase 3

Phase

—

Target enrolment

—

Study sites

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Pain Intensity in the ED
Measured over Pain intensity rating in the ED at 1-hour post-study drug administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03436121 on ClinicalTrials.gov →

Last updated in the registry 2020-02-11. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication