Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 17
Healthy Volunteers: t
View:
• Age \>= 3 and \< 18 years
• Elective tonsillectomy +/- adenoidectomy
• Signed informed consent by parent or legal guardian
• Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent
• Negative pregnancy test within 48 hours for post pubescent females
Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Lisa M Einhorn, MD
lisa.einhorn@duke.edu
9196814877
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 440
Treatments
Active_comparator: Short acting opioids: Fentanyl/Hydromorphone
Per Routine Care
Active_comparator: Long acting opioid: Methadone
Initial Dosing: 0.15 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.2 mg/kg age-ideal body weight in adolescents age 12 - 17 years.~Dose escalation (possible, based on interim analysis): 0.2 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.25 mg/kg age-ideal body weight in adolescents age 12 - 17 years.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)