Recruiting

Analgesic Regimen

Sponsor:

University of Michigan

Code:

NCT06671002

Conditions

Surgery

Pain, Post Operative

Eligibility Criteria

Sex: All

Age: 12 - 20

Healthy Volunteers: Not accepted

Interventions

NSAID

Opioid

Acetaminophen

Ibuprofen

Study Details

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?

Conditions

Surgery

Pain, Post Operative

Study ID

NCT06671002

Start date

Jan 10, 2025

Status verified date

Feb, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 20

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Acetaminophen/NSAID regimen

other: Acetaminophen/NSAID/Opioid regimen

Interventions

NSAID

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

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

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

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)

Primary outcome measure

  • Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery [ Time Frame: 14 days post-surgery, and up to 12 months after surgery ]
  • Safety outcome - number and severity of any adverse medication-related symptoms over 14 days post-surgery [ Time Frame: 14 days post-surgery, and 1 month after surgery ]

Central Contacts and Locations

Central contacts

Sarah Clark

734-232-0324sarahmcl@umich.edu

Locations

Children's Hospital Los Angeles (CHLA)

Recruiting

Los Angeles, California, United States, 90027

Contacts

Nikhita Datar, MS

323-361-7218ndatar@chla.usc.edu

Principal Investigator:

Lorraine Kelley-Quon, MD

Lucile Packard Children's Hospital Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Ryan Ma, BA

650-665-9074ryanma@stanford.edu

Principal Investigator:

Jennifer Rabbitts, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Sarah Clark

734-232-0324sarahmcl@umich.edu

Principal Investigator:

Mark Bicket, MD, PhD

Nationwide Children's (NCH)

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Taha Akbar, BS

614-355-4526taha.akbar@nationwidechildrens.org

Principal Investigator:

Sara Mansfield, MD

More Information

Sponsor

University of Michigan

Last update posted

Mar 4, 2026

Last verified

Feb, 2026

Keywords

  • Medications after surgery
  • NSAIDS
  • Acetaminophen
  • Opioids
  • Analgesics, non-narcotic
  • Tonsil removal
  • Gallbladder removal
  • Knee scope
  • Analgesics, opioid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-03-04.