Pediatric Pain Optimization After Tonsillectomy

Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Pain, Procedural; Tonsillitis
• Intervention / Treatment: Drug: Fentanyl/Hydromorphone; Drug: Methadone

Detailed Description

This is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children ages 3 to 17 years old
• Presenting for elective tonsillectomy +/- adenoidectomy
• Provide informed consent / assent (as appropriate)

Exclusion Criteria:

• History of liver or kidney disease
• Females with positive pregnancy test
• Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) > 10)
• Consistent daily opioid use for chronic pain ( >3 months)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Short acting opioids: Fentanyl, Hydromorphone	Drug: Fentanyl/Hydromorphone; Per routine care
Active Comparator: Long Acting Opioid: Methadone	Drug: Methadone; Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Amount of Opioid Medications Administered	Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram	Up to 7 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain	The PPPM has 15 yes/no questions which results in a score from 0-15, where a higher score indicates greater pain. A score of at least 6 out of 15 signifies clinically significant pain. The percentage of scores > or = 6 is shown below.	Up to 7 days post surgery
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale	Patient caregiver (as proxy) pain scores over past 7 days. Scale of 1 to 6, where 1=had no pain and 6=almost always had pain.	Up to 7 days post surgery
Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale	Numeric Pain Rating Scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.	Up to 7 days post surgery
Doses of Prescription Opioid Used Following Hospital Discharge	Number of doses of prescription medication used.	Up to 7 days post surgery
Opioid Administration in the PACU (Post-anesthesia Care Unit)	Opioid medication use in the recovery room expressed in oral morphine equivalents (OME) per kilogram.	Up to 6 hours post surgery

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Lisa M Einhorn, MD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Sleep Apnea Syndromes; Pharyngitis; Sleep Apnea, Obstructive; Pain, Procedural; Tonsillitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Respiratory System Agents; Antitussive Agents; Fentanyl; Hydromorphone; Methadone
• Other Study ID Numbers: Pro00109911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes