Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

NCT06576830 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: Pro001146771R01HD114678-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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

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

Keywords

Methadone; Tonsillectomy; Opioid

Outcome Measures

Primary Outcomes (1)

• Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)

  Binary (yes/no) need for opioid in the PACU

  Up to 6 hours post surgery

Secondary Outcomes (5)

• Total amount of opioid medication administered

  Up to 7 days post surgery

• Opioid administration in the PACU (post-anesthesia care unit)

  Up to 6 hours post surgery

• Opioid administration post PACU (post-anesthesia care unit)

  Up to 7 days post surgery

• Evaluation of participant's pain as measured by Numeric Pain Rating Scale

  Up to 7 days post surgery

• Number of participants with adverse event in the PACU (post-anesthesia care unit)

  Up to 6 hours post surgery

Study Arms (2)

Short acting opioids: Fentanyl/Hydromorphone

ACTIVE COMPARATOR

Per Routine Care

Drug: Fentanyl/Hydromorphone

Long acting opioid: Methadone

ACTIVE COMPARATOR

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.

Drug: Methadone

Interventions

Methadone DRUG

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

Long acting opioid: Methadone

Fentanyl/Hydromorphone DRUG

Per routine care, given as needed

Short acting opioids: Fentanyl/Hydromorphone

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Negative pregnancy test within 48 hours for post pubescent females

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (1)

• Einhorn LM, Hoang J, La JO, Kharasch ED. Single-dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double-blind Clinical Trial. Anesthesiology. 2024 Sep 1;141(3):463-474. doi: 10.1097/ALN.0000000000005031.

  PMID: 38669011 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Tonsillitis; Sleep Apnea Syndromes

Interventions

Methadone; Fentanyl; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Lisa M. Einhorn, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M Einhorn, MD

CONTACT

9196814877; lisa.einhorn@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Per NIH guidelines. Data will be available indefinitely.
• Access Criteria: NICHD DASH

Locations

US (1)