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RECRUITING Phase 4 ClinicalTrials.gov

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Sponsor: University of Michigan • ClinicalTrials.gov ID: NCT06671002

Registry updated: 2026-10-20
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Description

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?

Interventions

  • NSAID (Drug)
    Once randomized to this group the surgical team will elect to prescribe 1 of the following treatment options for post-discharge pain: * Ibuprofen 10 milligrams(mg)/kilogram (kg) (maximum 600mg) by mouth every 6 hours around the clock for 2 days, then as needed for pain thereafter (40 doses) * Celecoxib 6mg/kg (maximum 400mg) by mouth once then 3 mg/kg (maximum 200mg) every 12 hours around the clock for 2 days, then as needed for pain thereafter (40 doses)
  • Opioid (Drug)
    Once randomized to this group the surgical team will elect to prescribe for 1 of the following treatment options to be given post procedure for post-discharge pain: * Oxycodone 0.1 mg/kg (maximum 5 mg) by mouth every 4 to 6 hours as needed for pain, number 10 doses. * Hydromorphone 0.04 mg/kg (maximum mg) by mouth 4 to 6 hours as needed, number 10 doses
  • Acetaminophen (Drug)
    Participants will receive 15mg/kg up to 1000mg by mouth every 6 hours around the clock for the first 2 days after discharge from surgery then as needed thereafter (40 doses)
  • Ibuprofen (Drug)
    Ibuprofen 10mg/kg (maximum 600 mg) by mouth every 6 hours around the clock for 2 days after discharge from surgery then as needed thereafter (40 doses)

Eligibility criteria

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 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). 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 Complexity Algorithm (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 be excluded. * Liver disease * Acute psychiatric instability (defined as current uncontrolled severe depression, severe post-traumatic stress disorder (PTSD), or suicidal ideation), substance use disorder not in remission or treatment, and history of diversion of controlled substances (opioids)

Conditions

Surgery Pain, Post Operative

Locations

  • Phoenix Children's — Phoenix, Arizona, United States
  • Children's Hospital Los Angeles (CHLA) — Los Angeles, California, United States
  • Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States
  • Children's Hospital Colorado — Aurora, Colorado, United States
  • Kapi'olani Medical Center for Women & Children — Honolulu, Hawaii, United States
  • University of Michigan — Ann Arbor, Michigan, United States
  • Cincinnati Children's — Cincinnati, Ohio, United States
  • Nationwide Children's (NCH) — Columbus, Ohio, United States
  • Children's Wisconsin — Milwaukee, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record