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Comparing Pain Relief Options After Surgery for Kids

This study is looking at the best ways to manage pain after surgery for young people aged 12 to 20. It compares two common approaches: using non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen along with acetaminophen, or using low-dose opioids (like oxycodone or hydromorphone) along with NSAIDs and acetaminophen. You would be randomly assigned to one of these groups. The study wants to find out which option works best for pain relief and has the fewest side effects after surgeries like tonsil removal, gallbladder removal, or knee scope. We'll be looking at your pain intensity and any side effects for up to 12 months after surgery. The study plans to enroll 900 participants, but its current status is unclear.

Study design
This is an interventional study that will randomly assign participants to one of two treatment groups. It plans to enroll 900 participants aged 12 to 20.
What's involved
You would receive pain medication prescriptions after surgery and your pain intensity and any medication-related side effects would be monitored for up to 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your pain intensity will be measured up to 12 months after surgery, and medication-related side effects will be monitored for up to 1 month after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06671002

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Recruiting
PHASE4Ages 12–20InterventionalTreatment
University of Michigan
~900 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:NSAIDOpioidAcetaminophenIbuprofen

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery
Measured over 14 days post-surgery, and up to 12 months after surgery
+1 more outcome measured

Conditions

Surgery
Pain, Post Operative

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ArthroscopyCholecystectomyTonsillectomy

Where it's being run

4 sites across 3 states
California2
Michigan1
Ohio1

Study leadership

  • Mark Bicket, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Sarah Clark
[email protected]
734-232-0324
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery14 days post-surgery, and up to 12 months after surgery

    This is a one question survey in which the worst pain intensity recorded (0-10 being the worst) will be used.

  • Safety outcome - number and severity of any adverse medication-related symptoms over 14 days post-surgery14 days post-surgery, and 1 month after surgery

    Symptom Checklist will proactively screen patients for reports of adverse events from analgesic medications over the first 14 days post-surgery.