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Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Study acronym: OPTIMAL
StatusRecruiting
PhasePhase 4
Started2024-11-21
View on ClinicalTrials.gov ↗

Amendment history

2025-12-01
Study Status v4
Re-verified, no change to tracked fields
2025-07-22
Study Status, Sponsor/Collaborators v3
Primary completion date2029-09-30→2028-12-31
Completion date2029-09-30→2029-06-01
Collaborators1 to 2 entries
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2025-06-03
Study Status, Eligibility v2
Eligibility criteria-46 characters
[...] liver disease Current diagnosis of a chronic pain disorder Severe sleep apnea: Apnea Hypopnea Index > 10 Planned admission to the Pediatric Intensive Care Unit (PICU [...]
2024-11-21
Not Yet Recruiting→Recruiting Study Identification, Study Status, Conditions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-01→confirmed 2024-11-21
Study sitesdetails revised at 1 of 1 site
Study title+3 characters
IntraoperativeOptimization Methadone forof Pediatric Tonsillectomy Painto IMprove AnaLgesia
2024-08-27
Original filing
Duke University
455 trials monitored
See 53 trials at risk
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.
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