Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia (OPTIMAL)

Duke University

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative; Sleep-Disordered Breathing; Tonsillitis; Pediatric Sleep Apnea; Tonsillar Hypertrophy

Treatments: Drug: Fentanyl/Hydromorphone; Drug: Methadone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06576830

1R01HD114678-01 (U.S. NIH Grant/Contract)

Pro00114677

Details and patient eligibility

About

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.

Full 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 adolescents to 0.2 mg/kg age-ideal body weight. When an age cohort reaches 66 patients, this is the end of the first period. At that time, an unblinded interim analysis will be conducted in that cohort to determine if dose escalation to 0.2 mg/kg dose in children and the 0.25 mg/kg dose in adolescents are met. Methadone dose escalation will be based on clinically meaningful differences in need for rescue opioid in the PACU and the absence of well-defined opioid adverse events. Outcomes data will be collected in hospital and after discharge. With daily surveys for 7 days, and 3 phone calls on day 30, 3 months and 6 months after surgery.

Enrollment: 440 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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440 participants in 2 patient groups

Short acting opioids: Fentanyl/Hydromorphone

Active Comparator group

Description:

Per Routine Care

Treatment:

Drug: Fentanyl/Hydromorphone

Long acting opioid: Methadone

Active Comparator group

Description:

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.

Treatment:

Drug: Methadone