Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial
Duke University
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.
Description
This is a randomized, double-blind, parallel-group, dose-escalation investigation. Participants ("children" defined as ages 3 - \< 12 years and "adolescents" defined as ages 12 - 17 years) will be randomized 2:1 to either methadone or short-acting opioid. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. The trial will include 2 periods in 3 parallel age groups. In the first period, each age cohort will recruit 66 patients (44 methadone, 22 control). Children will be randomized to methadone 0.15 mg/kg age-ideal body weight and adoles…
Eligibility
- Age range
- 3–17 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age \>= 3 and \< 18 years 2. Elective tonsillectomy +/- adenoidectomy 3. Signed informed consent by parent or legal guardian 4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent 5. Negative pregnancy test within 48 hours for post pubescent females Exclusion Criteria: 1. History of chronic kidney or liver disease 2. Current diagnosis of a chronic pain disorder 3. Planned admission to the Pediatric Intensive Care Unit (PICU) 4. Additional procedures under general anesthesia for which opioids would be prescribed
Interventions
- DrugMethadone
Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.
- DrugFentanyl/Hydromorphone
Per routine care, given as needed
Location
- Duke University Medical CenterDurham, North Carolina