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TerminatedPhase 4Results posted

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

NCT03305055 · Johns Hopkins University

Closed to entry
Status
Not accepting participants
Phase 4
Phase
4
Target enrolment
1
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Mean Wound Care Pain

    Measured over Up to 40 days

  • Trajectory of Mean Wound Care Session Pain Within Sessions

    Measured over 7-days, within session

  • Trajectory of Mean Wound Care Session Pain Across Sessions

    Measured over 7-Days across sessions

  • Opiate Sparing Effect

    Measured over 37 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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 Criteria: * 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)

Where

1 study site

FacilityCityRegionCountry
Johns Hopkins Burn CenterBaltimoreMarylandUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03305055 on ClinicalTrials.gov →

Last updated in the registry 2019-03-12. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 34 trials from Johns Hopkins University →