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

• Status: Terminated
• Trial end date: 2018-04-21
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Congressionally Directed Medical Research Programs; United States Department of Defense
• Treatments: Fentanyl; Ketamine

Criteria

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)
• 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)