Clinical Trial

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Study acronym: OPTIMAL
Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-08-27; most recent amendment 2025-12-01.
Status change: Not Yet Recruiting → Recruiting 2024-11-21
Trial Details
NCT Number NCT06576830
Lead Sponsor Duke University
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis, Pediatric Sleep Apnea, Sleep-Disordered Breathing
Enrollment 440 participants
Start Date 2024-11-21
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-05