NCT06671002 Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
| NCT ID | NCT06671002 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Michigan |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-10-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 900 participants in total. It began in 2025-01-10 with a primary completion date of 2026-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Mark Bicket, MD, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06671002 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 20 Years, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06671002 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06671002 currently recruiting?
Yes, NCT06671002 is actively recruiting participants. Contact the research team at sarahmcl@umich.edu for enrollment information.
Where is the NCT06671002 trial being conducted?
This trial is being conducted at Los Angeles, United States, Palo Alto, United States, Ann Arbor, United States, Columbus, United States.
Who is sponsoring the NCT06671002 clinical trial?
NCT06671002 is sponsored by University of Michigan. The principal investigator is Mark Bicket, MD, PhD at University of Michigan. The trial plans to enroll 900 participants.