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Phase 4
Age: 18Years +
All Genders
ID06506565

Study of Low-Dose Ketamine Infusion to Reduce Pain and Opioid Use During Burn Wound Care Randomized, Placebo-Controlled, Double-Blind Phase 4 Trial

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 mgkghr 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%

Research Team

D

David M Hill, Pharm.D.

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