Actively Recruiting
Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia
Led by Duke University · Updated on 2025-12-05
440
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.
CONDITIONS
Official Title
Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 to under 18 years
- Elective tonsillectomy with or without adenoidectomy
- Signed informed consent by parent or legal guardian
- Children 12 years and older must provide signed written consent
- Children 7 years and older must provide verbal assent
- Negative pregnancy test within 48 hours for post-pubescent females
You will not qualify if you...
- History of chronic kidney or liver disease
- Current diagnosis of a chronic pain disorder
- Planned admission to the Pediatric Intensive Care Unit (PICU)
- Additional procedures under general anesthesia requiring opioids
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
L
Lisa M Einhorn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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