Actively Recruiting
Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
Led by University of Michigan · Updated on 2026-03-04
900
Participants Needed
4
Research Sites
146 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No significant use of opioid pain medications for 6 days or more in the past 90 days before surgery, except prescriptions within the week of surgery
- Undergoing tonsil removal (with or without adenoid removal), laparoscopic gallbladder removal, or knee scope (arthroscopy) surgery
You will not qualify if you...
- Planned additional surgery within 12 months
- Expected life expectancy less than 12 months
- Under legal guardianship requiring special permission for trial enrollment
- Have complex chronic conditions such as trisomy 21
- Contraindications to NSAIDs, opioids, or acetaminophen depending on assigned treatment group
- Known liver disease
- Current severe uncontrolled psychiatric conditions, including severe depression, severe PTSD, suicidal thoughts, untreated substance use disorder, or history of opioid diversion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Children's Hospital Los Angeles (CHLA)
Los Angeles, California, United States, 90027
Actively Recruiting
2
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Nationwide Children's (NCH)
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
S
Sarah Clark
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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