Comparing pain relief options for children after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares the effectiveness and safety of two pain management regimens for children recovering from surgery. Participants who undergo elective tonsil removal, gallbladder removal, or knee arthroscopy will be randomly assigned to receive either a combination of NSAIDs and acetaminophen or a low dose of opioids along with NSAIDs and acetaminophen. The study aims to determine which medication regimen provides better pain relief with fewer side effects.

Why it matters

Who can join: the full rules

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)

Where it's running

• Children's Hospital Los Angeles (CHLA)
  Los Angeles, California, United States Recruiting
• Lucile Packard Children's Hospital Stanford
  Palo Alto, California, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Nationwide Children's (NCH)
  Columbus, Ohio, United States Recruiting
• Phoenix Children's
  Phoenix, Arizona, United States Active not recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Active not recruiting

Study contacts

• Principal investigator: Mark Bicket, MD, PhD — University of Michigan
• Study coordinator: Sarah Clark
• Email: sarahmcl@umich.edu
• Phone: 734-232-0324

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.