Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Recruiting now · Phase 4

Conditions studied: Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis, Pediatric Sleep Apnea, Sleep-Disordered Breathing

In brief

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.

Key facts

Study ID

NCT06576830

Run by

Duke University

People needed

440

Starts

2024-11-21

Expected to finish

2029-06-01

Last updated by the study team

2025-12-05

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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