Optimizing Pain Control After Tonsillectomy in Children and Adolescents

This study is looking at ways to improve pain control after tonsillectomy (surgery to remove tonsils) in children and adolescents aged 3 to 17. Researchers are comparing two types of pain medication given during surgery: methadone, a long-acting opioid, versus fentanyl or hydromorphone, which are shorter-acting opioids given as needed. The main goal is to see if methadone can reduce the need for additional pain medication in the recovery room after surgery. You might be eligible if you are having an elective tonsillectomy and meet other health criteria. The study aims to enroll 440 participants, but its current status is unclear.

Study design
This is a randomized, double-blind study where participants are assigned to either methadone or short-acting opioids, with 440 participants planned.
What's involved
You would have outcomes data collected in the hospital, daily surveys for 7 days after discharge, and three phone calls at 30 days, 3 months, and 6 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06576830

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Recruiting
PHASE4Ages 3–17InterventionalTreatment
Duke University
~440 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:MethadoneFentanyl/Hydromorphone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)
Measured over Up to 6 hours post surgery
Pain, Postoperative
Tonsillar Hypertrophy
Tonsillitis
Pediatric Sleep Apnea
Sleep-Disordered Breathing
1 sites across 1 states
North Carolina1
  • Lisa M. Einhorn, MD · PRINCIPAL_INVESTIGATOR · Duke University

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  • Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)Up to 6 hours post surgery

    Binary (yes/no) need for opioid in the PACU