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Low-Dose Ketamine for Burns (IMPROVE Trial)

Phase 4
Recruiting
Research Sponsored by University of Tennessee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to burn service with thermal injury
Be older than 18 years old
Must not have
Less than 18 years of age
Known contraindication to ketamine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days from enrollment
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to see if adding a small amount of ketamine during wound care for burn patients can safely reduce pain better than the current standard treatment of fentanyl and midazolam.

Who is the study for?
This trial is for patients with burn injuries who experience pain during wound care. It aims to see if low-dose ketamine can help manage their pain better than the current standard treatments without increasing opioid use.
What is being tested?
The study tests whether a low dose of ketamine, given as an infusion alongside the usual care (like fentanyl and midazolam), can provide better pain relief during burn wound care compared to just using the standard medications alone.
What are the potential side effects?
Ketamine may cause side effects such as feeling disconnected from reality (dissociation), changes in blood pressure, nausea, or hallucinations. The severity of these side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was admitted for a burn injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I cannot take ketamine due to health reasons.
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More than half of my body is affected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days from enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Analgesia

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KetamineExperimental Treatment1 Intervention
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: PlaceboPlacebo Group1 Intervention
0.9% saline to begin 1 hour before wound care, continuing through and for 1 hour following wound care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

University of TennesseeLead Sponsor
195 Previous Clinical Trials
144,465 Total Patients Enrolled
~93 spots leftby Dec 2025
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