Low-Dose Ketamine Infusion During Burn Wound Care

NCT06506565 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 23-09751-FB
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn; Pain; Dissociation; Opioid

Keywords

ketamine; burn; opioid; analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: 0.9% NaCl

Interventions

Ketamine DRUG

Infusion during wound care

Ketamine

0.9% NaCl DRUG

Infusion during wound care

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to burn service with thermal injury

You may not qualify if:

• 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 %

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Regional One Health

Memphis, Tennessee, 38103, United States

RECRUITING

MeSH Terms

Conditions

Burns; Pain; Dissociative Disorders; Agnosia

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

David M Hill, Pharm.D.

CONTACT

1-901-545-7100; dhill19@uthsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All team members and patients are blinded to study treatment, except pharmacy staff.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly enrolled by blocks according to age, burn size, and opioid use history. Study treatment will occur for up to 7 days. Assignment will be to placebo or ketamine and all participants and staff will be blinded, except pharmacy. Each patient will receive standard of care fentanyl and midazolam during wound care regardless of study assignment.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 8, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)