Pediatric Pain Optimization After Tonsillectomy
1 other identifier
interventional
66
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedStudy Start
First participant enrolled
April 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2023
CompletedResults Posted
Study results publicly available
October 17, 2024
CompletedOctober 17, 2024
October 1, 2024
1.1 years
February 8, 2022
March 20, 2024
October 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram
Up to 7 days post surgery
Secondary Outcomes (5)
Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain
Up to 7 days post surgery
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale
Up to 7 days post surgery
Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale
Up to 7 days post surgery
Doses of Prescription Opioid Used Following Hospital Discharge
Up to 7 days post surgery
Opioid Administration in the PACU (Post-anesthesia Care Unit)
Up to 6 hours post surgery
Study Arms (2)
Short acting opioids: Fentanyl, Hydromorphone
ACTIVE COMPARATORLong Acting Opioid: Methadone
ACTIVE COMPARATORInterventions
Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis
Eligibility Criteria
You may qualify if:
- Children ages 3 to 17 years old
- Presenting for elective tonsillectomy +/- adenoidectomy
- Provide informed consent / assent (as appropriate)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University School of Medicine
Durham, North Carolina, 27710, United States
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: 38669011RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Einhorn, MD
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa M Einhorn, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
February 8, 2022
First Posted
February 17, 2022
Study Start
April 8, 2022
Primary Completion
May 10, 2023
Study Completion
May 10, 2023
Last Updated
October 17, 2024
Results First Posted
October 17, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share