Pediatric Pain Optimization After Tonsillectomy

Phase 2

Completed

• Conditions: Tonsillitis; Pain, Procedural; Obstructive Sleep Apnea
• Interventions: Drug: Fentanyl/Hydromorphone; Drug: Methadone

• Registration Number: NCT05244226
• 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.

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 Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-17
• Study Start: 2022-04-08
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-10
• Results First Submitted: 2024-03-20
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Results First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short acting opioids: Fentanyl, Hydromorphone	Fentanyl/Hydromorphone	-
Long Acting Opioid: Methadone	Methadone	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain	Up to 7 days post surgery	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.
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale	Up to 7 days post surgery	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.
Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale	Up to 7 days post surgery	Numeric Pain Rating Scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.
Doses of Prescription Opioid Used Following Hospital Discharge	Up to 7 days post surgery	Number of doses of prescription medication used.
Opioid Administration in the PACU (Post-anesthesia Care Unit)	Up to 6 hours post surgery	Opioid medication use in the recovery room expressed in oral morphine equivalents (OME) per kilogram.

Trial Locations

Locations (1)

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States