Actively Recruiting

Phase 4
Age: 12Years - 20Years
All Genders
NCT06671002

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

Age: 12Years - 20Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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