About this trial

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 criteria

Qualifiers

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

Disqualifiers

History of chronic kidney or liver disease

Current diagnosis of a chronic pain disorder

Planned admission to the Pediatric Intensive Care Unit (PICU)

Additional procedures under general anesthesia for which opioids would be prescribed

Trial design

Treatments tested in this trial

  • Methadone
  • Fentanyl/Hydromorphone

Treatment groups

440 Participants
are divided into 2 treatment groups

Locations

1
Duke University Medical Center27710, DurhamNorth Carolina, United States

Sponsors and collaborators

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

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

Collaborator