Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Admitted to burn service with thermal injury
- Age 18 years or older
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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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