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RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain

NCT03305055 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-03-12

Study results available
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Summary

The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual Care-Opiate (UC-O), dose/timing as per Burn Center protocol).

Conditions

Interventions

DRUG

ketamine

Information included in arm descriptions

DRUG

Fentanyl

Information included in arm descriptions

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • James A Fauerbach, PhD · Johns Hopkins University SOM

  • Kevin Gerold, DOJD · Johns Hopkins University SOM

  • Julie Caffrey, DO · Johns Hopkins University SOM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-16
Primary Completion
2018-03-28
Completion
2018-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03305055 on ClinicalTrials.gov