Status:
RECRUITING
Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pain, Postoperative
Tonsillar Hypertrophy
Eligibility:
All Genders
3-17 years
Phase:
PHASE4
Brief Summary
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 a...
Detailed Description
This is a randomized, double-blind, parallel-group, dose-escalation investigation. Participants ("children" defined as ages 3 - \< 12 years and "adolescents" defined as ages 12 - 17 years) will be ran...
Eligibility Criteria
Inclusion
- Age \>= 3 and \< 18 years
- Elective tonsillectomy +/- adenoidectomy
- Signed informed consent by parent or legal guardian
- Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent
- Negative pregnancy test within 48 hours for post pubescent females
Exclusion
- 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 for which opioids would be prescribed
Key Trial Info
Start Date :
November 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT06576830
Start Date
November 21 2024
End Date
June 1 2029
Last Update
December 5 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710