Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-20
SponsorUniversity of Michigan
About this trial
This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Eligible participants will be randomized to prescription of 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) plus acetaminophen or low dose opioids with the NSAIDs plus acetaminophen. The key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?
Eligibility criteria
Qualifiers
No significant analgesic medication use before surgery as defined in the protocol. For this study, we define significant analgesic medication use before surgery as prescriptions reported by the child or caregiver for 6 days or more of opioid medications in the past 90 days (aligning with American Pediatric Guidelines that were published in September 2024 after the project was funded), excepting surgical team prescriptions within the week of surgery.
Undergo one the following: tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).
Disqualifiers
Anticipated other surgery within 12 months
Anticipated life expectancy of <12 months
Those that have legal guardians (due to special permission to enroll in trials)
Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
Trial design
Treatments tested in this trial
- NSAID
- Opioid
- Acetaminophen
- Ibuprofen
Treatment groups
900 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Michigan
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov