Recruiting

Pediatric Tonsillectomy

Sponsor:

Duke University

Code:

NCT06576830

Conditions

Pain, Postoperative

Tonsillar Hypertrophy

Tonsillitis

Pediatric Sleep Apnea

Sleep-Disordered Breathing

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

Interventions

Methadone

Fentanyl/Hydromorphone

Study Details

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.

Conditions

Pain, Postoperative

Tonsillar Hypertrophy

Tonsillitis

Pediatric Sleep Apnea

Sleep-Disordered Breathing

Study ID

NCT06576830

Start date

Nov 21, 2024

Status verified date

Dec, 2025

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Short acting opioids: Fentanyl/Hydromorphone

Per Routine Care

active comparator: Long acting opioid: 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.

Interventions

Methadone

Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.

Fentanyl/Hydromorphone

Per routine care, given as needed

Primary outcome measure

  • Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit) [ Time Frame: Up to 6 hours post surgery ]

Central Contacts and Locations

Central contacts

Lisa M Einhorn, MD

9196814877lisa.einhorn@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Lisa Einhorn

lisa.einhorn@duke.edu

Principal Investigator:

Lisa M. Einhorn, M.D.

More Information

Sponsor

Duke University

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • Methadone
  • Tonsillectomy
  • Opioid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-12-05.