Low-Dose Ketamine Infusion During Burn Wound Care (IMPROVE)

University of Tennessee

Status and phase: Enrolling; Phase 4

Conditions: Dissociation; Opioid; Pain; Burn

Treatments: Drug: 0.9% NaCl; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06506565

23-09751-FB

Details and patient eligibility

About

The current standard of care (SOC) (i.e. fentanyl and midazolam) offers limited efficacy for preventing or relieving pain. Ketamine infusions may provide the benefits of analgesia, minimize adverse events, and reduce opioid use. The purpose of this study is to determine if adding a low dose ketamine infusion during wound care will safely provide pain relief for patients with burn injury.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to burn service with thermal injury

Exclusion criteria

• unable/unwilling to consent within 72 hours
• unable to report NRS
• known contraindication to ketamine
• < than 18 years of age
• pregnant
• incarcerated
• TBSA over 50 %

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Ketamine

Experimental group

Description:

Ketamine infusion (0.3 mg/kg/hr) to begin 1 hour before wound care, continuing through and for 1 hour following wound care.

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

0.9% saline to begin 1 hour before wound care, continuing through and for 1 hour following wound care.

Treatment:

Drug: 0.9% NaCl