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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.
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.
Age
3 - 17 years
Sex
ALL
Healthy Volunteers
Yes
Duke University School of Medicine
Durham, North Carolina, United States
Start Date
April 8, 2022
Primary Completion Date
May 10, 2023
Completion Date
May 10, 2023
Last Updated
October 17, 2024
66
ACTUAL participants
Fentanyl/Hydromorphone
DRUG
Methadone
DRUG
Lead Sponsor
Duke University
NCT06430957
NCT07292922
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07225686