Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06506565

A Randomized, Placebo-Controlled, Double-Blind Study Evaluating Low-Dose Ketamine Infusion During Burn Wound Care for Pain Relief and Opioid Reduction

Led by University of Tennessee · Updated on 2024-12-13

140

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding a low-dose ketamine infusion during burn wound care can safely relieve pain and reduce opioid use compared to the current standard treatment with fentanyl and midazolam. This phase 4 randomized, placebo-controlled, and double-blind study aims to improve pain management for patients with burn injuries. The study is sponsored by the University of Tennessee and focuses on assessing analgesia and opioid consumption during wound care procedures. Participants will receive either a ketamine infusion at 0.3 mg/kg/hr or a saline placebo. The infusion starts one hour before wound care, continues during the procedure, and lasts for one hour afterward. Two study arms compare ketamine to placebo to determine if ketamine provides better pain relief and reduces opioid needs. During the study, participants will be closely monitored for pain levels using numeric rating scales and opioid consumption for up to seven days after enrollment. Safety and pain relief will be assessed to understand the effects of ketamine in this setting. The trial includes follow-up visits and evaluations to track outcomes and adverse events over this period.

CONDITIONS

Brief Title

Low-Dose Ketamine Infusion During Burn Wound Care

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to burn service with thermal injury
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Unable or unwilling to consent within 72 hours
  • Unable to report pain using numeric rating scale
  • Known contraindication to ketamine
  • Younger than 18 years
  • Pregnant
  • Incarcerated
  • Total body surface area burned over 50%

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 7 days from enrollment

Participants receive low-dose ketamine or placebo infusion starting 1 hour before burn wound care and continuing through and for 1 hour following wound care.

Infusion during wound care visits

Trial Site Locations

Total: 1 location

1

Regional One Health

Memphis, Tennessee, United States, 38103

Actively Recruiting

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Research Team

D

David M Hill, Pharm.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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