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

Ketamine

Brief 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).

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Midazolam
  • Drug: Placebo

Condition or Disease

  • Acute Pain
  • Depression

Phase

Study Design

Study type: Interventional
Status: Withdrawn
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 0 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Dec 19, 2020
Primary Completion: Feb 05, 2020
Completion Date: Feb 05, 2020
Study First Posted: Feb 19, 2018
Results First Posted: Aug 31, 2020
Last Updated: Feb 11, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

The investigators will enroll 120 medically stable adult patients who present to two Emergency Departments with a chief complaint of acute pain.

The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of IV ketamine (0.3 mg.kg) + midazolam, or 2) placebo + midazolam. ED providers and patients will be blind to treatment allocation.

All participants will complete measures of pain and mood scores every 30 minutes, and the investigators will record any analgesics administered in the ED until discharge. At 7-days and 14-days post- discharge, the investigators will measure summary reports of pain severity, mood, and analgesic medication used.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 65

More Details

NCT Number: NCT03436121
Other IDs: PRO17090065
Study URL: https://ClinicalTrials.gov/show/NCT03436121
Last updated: Mar 18, 2021