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

NCT03436121 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2020-02-11

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Ketamine

Ketamine is a medication approved by the US Food and Drug Administration (FDA) for anesthesia, sedation, and post-surgical pain treatment. It is not approved for emergency patients complaining of pain but is often used "off-label." Ketamine may be useful for acute pain management and in treatment of depressed mood. The purpose of this study is to determine whether a single low dose of ketamine can relieve pain and reduce negative mood for 2 weeks after emergency department (ED) treatment.

DRUG

Midazolam

In this study, all patients will also receive midazolam. Midazolam is a sedative that typically makes people feel relaxed and is intended to increase comfort with ketamine and reduce anxiety.

DRUG

Placebo

In this study, patients in the active comparator group will receive midazolam first, then placebo. A placebo is an inactive solution that looks like the study drug, but contains no active ingredients.

Sponsors & Collaborators

  • University of Pittsburgh Physicians

    collaborator OTHER

  • Maria Pacella

    lead OTHER

Principal Investigators

  • Maria L Pacella, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2020-02-05
Completion
2020-02-05
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03436121 on ClinicalTrials.gov