Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Last updated: March 2, 2026
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

4

Condition

Surgery

Treatment

Ibuprofen

NSAID

Acetaminophen

Clinical Study ID

NCT06671002
HUM00252793
BPS-2023C1-32147
  • Ages 12-20
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • No significant analgesic medication use before surgery as defined in the protocol.For this study, we define significant analgesic medication use before surgery asprescriptions reported by the child or caregiver for 6 days or more of opioidmedications in the past 90 days (aligning with American Pediatric Guidelines thatwere published in September 2024 after the project was funded), excepting surgicalteam prescriptions within the week of surgery.

  • Undergo one the following: tonsil removal (with or without adenoid removal),gallbladder removal (laparoscopic), and knee scope (arthroscopy).

Exclusion

Exclusion Criteria:

  • 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 ComplexityAlgorithm (e.g., trisomy 21)

  • Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID)drugs in the NSAID arm, opioid drugs in the opioid arm, or acetaminophen will beexcluded.

  • Liver disease

  • Acute psychiatric instability (defined as current uncontrolled severe depression,severe post-traumatic stress disorder (PTSD), or suicidal ideation), substance usedisorder not in remission or treatment, and history of diversion of controlledsubstances (opioids)

Study Design

Total Participants: 900
Treatment Group(s): 4
Primary Treatment: Ibuprofen
Phase: 4
Study Start date:
January 10, 2025
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • Children's Hospital Los Angeles (CHLA)

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Lucile Packard Children's Hospital Stanford

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Nationwide Children's (NCH)

    Columbus, Ohio 43205
    United States

    Active - Recruiting

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