RecruitingPhase 4NCT06576830
Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia
Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial
Sponsor
Duke University
Enrollment
440 participants
Start Date
Nov 21, 2024
Study Type
INTERVENTIONAL
Conditions
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 adolescents.
Eligibility
Min Age: 3 YearsMax Age: 17 Years
Inclusion Criteria5
- 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 Criteria4
- 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
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Interventions
DRUGMethadone
Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.
DRUGFentanyl/Hydromorphone
Per routine care, given as needed
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06576830
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