Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

PHASE4RecruitingINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

November 21, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

June 1, 2029

Conditions
Pain, PostoperativeTonsillar HypertrophyTonsillitisPediatric Sleep ApneaSleep-Disordered Breathing
Interventions
DRUG

Methadone

Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.

DRUG

Fentanyl/Hydromorphone

Per routine care, given as needed

Trial Locations (1)

27710

RECRUITING

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Duke University

OTHER

NCT06576830 - Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia | Biotech Hunter | Biotech Hunter