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

Depression Clinical Trial

Official title: Single-dose Ketamine to Reduce Pain Severity, Depressive Symptoms and the Need for Opiates Both During and After Emergency Department Care

Status Withdrawn

Clinical Trial 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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Acute Pain
• Depression
• Depressive Disorder
• Emergencies

• NCT number: NCT03436121
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: December 2019
• Completion date: February 5, 2020