Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-17
SponsorDuke University

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

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