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Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial

Who can join

Ages 3 to 17 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

1. Age \>= 3 and \< 18 years
2. Elective tonsillectomy +/- adenoidectomy
3. Signed informed consent by parent or legal guardian
4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent
5. Negative pregnancy test within 48 hours for post pubescent females

Exclusion Criteria:

1. History of chronic kidney or liver disease
2. Current diagnosis of a chronic pain disorder
3. Planned admission to the Pediatric Intensive Care Unit (PICU)
4. Additional procedures under general anesthesia for which opioids would be prescribed

About the study

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.

What is being tested

• Methadone (drug)
• Fentanyl/Hydromorphone (drug)

Sponsor: Duke University · Participants: 440 · Started: Nov 21, 2024

Contact the study team

• Lisa M Einhorn, MD · Phone: 9196814877

Official record on ClinicalTrials.gov — NCT06576830

Locations in the U.S.

Conditions

• Pain After Surgery
• Sleep Apnea

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.