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

A Randomized, Placebo-Controlled, Double-Blind Evaluation of Low-Dose Ketamine Infusion During Burn Wound Care Procedures to Improve Pain Intensity and Reduce Opioid Consumption

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Burn; Dissociation; Opioid
• Intervention / Treatment: Drug: Ketamine; Drug: 0.9% NaCl

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David M Hill, Pharm.D.; Phone Number: 1-901-545-7100; Email: dhill19@uthsc.edu

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • Regional One Health
      • Contact: Yvonne Shaw, RN; Phone Number: 901-448-2714; Email: yshaw@uthsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine; Ketamine infusion (0.3 mg/kg/hr) to begin 1 hour before wound care, continuing through and for 1 hour following wound care.	Drug: Ketamine; Infusion during wound care
Placebo Comparator: Placebo; 0.9% saline to begin 1 hour before wound care, continuing through and for 1 hour following wound care.	Drug: 0.9% NaCl; Infusion during wound care; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Tennessee

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: opioid; ketamine; analgesia; burn
• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Burns; Dissociative Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Ketamine
• Other Study ID Numbers: 23-09751-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No