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Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Recruiting
12-20 years
All
Phase 4

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Overview

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

Inclusion Criteria:

  • No significant analgesic medication use before surgery as defined in the protocol
  • Undergo one the following: elective 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)

Study details
    Surgery
    Pain
    Post Operative

NCT06671002

University of Michigan

16 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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