Status:
COMPLETED
Pediatric Pain Optimization After Tonsillectomy
Lead Sponsor:
Duke University
Conditions:
Obstructive Sleep Apnea
Tonsillitis
Eligibility:
All Genders
3-17 years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- Children ages 3 to 17 years old
- Presenting for elective tonsillectomy +/- adenoidectomy
- Provide informed consent / assent (as appropriate)
Exclusion
- 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)
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05244226
Start Date
April 8 2022
End Date
May 10 2023
Last Update
October 17 2024
Active Locations (1)
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1
Duke University School of Medicine
Durham, North Carolina, United States, 27710