Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Phase 4

Recruiting

• Conditions: Pain, Postoperative; Tonsillar Hypertrophy; Tonsillitis; Pediatric Sleep Apnea; Sleep-Disordered Breathing
• Interventions: Drug: Fentanyl/Hydromorphone; Drug: Methadone

• Registration Number: NCT06576830
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-29
• Status Verified: 2024-11
• Study Start: 2024-11-21
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2029-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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. Severe sleep apnea: Apnea Hypopnea Index > 10
4. Planned admission to the Pediatric Intensive Care Unit (PICU)
5. Additional procedures under general anesthesia for which opioids would be prescribed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short acting opioids: Fentanyl/Hydromorphone	Fentanyl/Hydromorphone	Per Routine Care
Long acting opioid: Methadone	Methadone	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)	Up to 6 hours post surgery	Binary (yes/no) need for opioid in the PACU

Secondary Outcome Measures

Name	Time	Method
Total amount of opioid medication administered	Up to 7 days post surgery	Postoperative opioid use expressed in morphine milligram equivalents per kilogram
Opioid administration in the PACU (post-anesthesia care unit)	Up to 6 hours post surgery	Postoperative opioid use in the recovery room expressed in morphine milligram equivalents per kilogram
Opioid administration post PACU (post-anesthesia care unit)	Up to 7 days post surgery	Postoperative opioid use after PACU discharge expressed in morphine milligram equivalents per kilogram
Number of participants with adverse event in the PACU (post-anesthesia care unit)	Up to 6 hours post surgery	Adverse events will only include those that are determined to be related to the study drugs.
Evaluation of participant's pain as measured by Numeric Pain Rating Scale	Up to 7 days post surgery	Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States