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).
Topic Depression
Pain
Country United States of America
Visit trial
Status
Withdrawn
Results Published
Start date
12 January 2019
End date
02 May 2020
Chance of happening
0%
Phase
Phase II
Phase III
Design
Blinded
Type
Interventional
Generation
First
Participants
0
Sex
All
Age
18- 65
Therapy
No
Trial Details
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.NCT Number NCT03436121
Sponsors & Collaborators
University of PittsburghThis company doesn't have a full profile yet, it is linked to a clinical trial.