Recruiting

IMPROVELow-Dose Ketamine for Pain Relief in Burn Wound Care

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Study Aim

This study aims to evaluate the effectiveness of low-dose ketamine in providing pain relief for adults undergoing burn wound care.

What is being tested

Ketamine

+ 0.9% NaCl

Drug
Who is being recruted

Agnosia+9

+ Mental Disorders

+ Burns

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorUniversity of Tennessee
Study ContactDavid M Hill, Pharm.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 8, 2024

Actual date on which the first participant was enrolled.

This study is looking at how a low dose of ketamine, given through an infusion, might help people with burn injuries feel less pain during wound care procedures. The usual pain relief medications, like fentanyl and midazolam, don't always work well enough on their own. This research aims to see if ketamine can make a difference by improving pain relief and potentially reducing the need for opioids, which can have serious side effects. This study is important as it seeks to find better ways to manage pain for burn patients, which can improve their overall recovery experience. Participants in the study will receive either a low dose of ketamine or a placebo while undergoing their regular burn wound care. The ketamine or placebo is administered through an infusion, which means it is delivered directly into the bloodstream. The study will measure how well the ketamine reduces pain during these procedures and whether it leads to a decrease in the use of opioids. By evaluating the pain levels and opioid consumption, researchers aim to determine if ketamine can be a safer and more effective option for managing pain in burn patients.

Official TitleA Randomized, Placebo-Controlled, Double-Blind Evaluation of Low-Dose Ketamine Infusion During Burn Wound Care Procedures to Improve Pain Intensity and Reduce Opioid Consumption
NCT06506565
Principal SponsorUniversity of Tennessee
Study ContactDavid M Hill, Pharm.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AgnosiaMental DisordersBurnsDissociative DisordersNervous System DiseasesNeurologic ManifestationsPainPerceptual DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesNeurobehavioral Manifestations

Criteria

1 inclusion criteria required to participate
Admitted to burn service with thermal injury

7 exclusion criteria prevent from participating
unable to report NRS

unable/unwilling to consent within 72 hours

known contraindication to ketamine

than 18 years of age

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Regional One Health

Memphis, United StatesOpen Regional One Health in Google Maps
Recruiting
One Study Center