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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Acute Pain, Wound Care, Posttraumatic Stress Disorder

In brief

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).

Key facts

Study ID

NCT03305055

Run by

Johns Hopkins University

People needed

4

Starts

2017-12-16

Expected to finish

2018-04-21

Last updated by the study team

2019-03-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Johns Hopkins Burn Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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