Status:
TERMINATED
RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
United States Department of Defense
Congressionally Directed Medical Research Programs
Conditions:
Acute Pain
Wound Care
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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...
Detailed Description
Department of Defense (DoD) and the U.S. Army Medical Research and Materiel Command (USAMRMC) are funding this RCT for the following reasons: Primary Aims: 1. To evaluate the safety and efficacy of ...
Eligibility Criteria
Inclusion
- Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40% TBSA
- English speaking
- pain in emergency room during initial wound evaluation (on admission) greater than 5 /10
- estimated length of stay greater than or equal to 5 days
Exclusion
- requiring endotracheal intubation and sedation,
- severe hearing impairment,
- cognitive impairment status - Mini-Mental State Examination (MMSE) \</=20,
- diminished capacity unable to provide informed consent;
- Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)
- Safety: contraindication (e.g., potential drug interactions or medical comorbidities)
Key Trial Info
Start Date :
December 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03305055
Start Date
December 16 2017
End Date
April 21 2018
Last Update
March 12 2019
Active Locations (1)
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1
Johns Hopkins Burn Center
Baltimore, Maryland, United States, 21224