Low-Dose Ketamine Infusion During Burn Wound Care

Phase 4

Recruiting

• Conditions: Burn; Pain; Dissociation; Opioid
• Interventions: Drug: Ketamine; Drug: 0.9% NaCl

• Registration Number: NCT06506565
• Lead Sponsor: University of Tennessee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 %

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	Ketamine infusion (0.3 mg/kg/hr) to begin 1 hour before wound care, continuing through and for 1 hour following wound care.
Placebo	0.9% NaCl	0.9% saline to begin 1 hour before wound care, continuing through and for 1 hour following wound care.

Primary Outcome Measures

Name	Time	Method
Analgesia	up to 7 days from enrollment	Numeric Pain Rating Scale (0 - 10, with 0 being absence of pain and 10 being the worst pain imaginable)

Trial Locations

Locations (1)

Regional One Health; 🇺🇸 Memphis, Tennessee, United States