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
This trial accepts healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Methadone
DrugSingle-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.
Fentanyl/Hydromorphone
DrugPer routine care, given as needed
Treatment groups
Trial outcomes
Primary outcomes
Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)
Binary (yes/no) need for opioid in the PACU
Secondary outcomes
Total amount of opioid medication administered
Postoperative opioid use expressed in morphine milligram equivalents per kilogram
Opioid administration in the PACU (post-anesthesia care unit)
Postoperative opioid use in the recovery room expressed in morphine milligram equivalents per kilogram
Opioid administration post PACU (post-anesthesia care unit)
Postoperative opioid use after PACU discharge expressed in morphine milligram equivalents per kilogram
Evaluation of participant's pain as measured by Numeric Pain Rating Scale
Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Sponsors and contacts
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Duke University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator