Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Michigan
Study ID
NCT06671002
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Pain, Post Operative
  • Surgery

Eligibility Criteria

Sex
ALL
Age
12 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • NSAID — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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)

Study Details

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?

Key Dates

Start date
Jan 10, 2025
Status verified
Feb 2026
Primary completion
Oct 16, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Acetaminophen/NSAID regimen
  • Other: Acetaminophen/NSAID/Opioid regimen

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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Hospital Los Angeles (CHLA)Los AngelesCalifornia90027
Nikhita Datar, MS
[email protected]
323-361-7218
Lorraine Kelley-Quon, MD (PRINCIPAL_INVESTIGATOR)
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304
Ryan Ma, BA
[email protected]
650-665-9074
Jennifer Rabbitts, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Sarah Clark
[email protected]
734-232-0324
Mark Bicket, MD, PhD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's (NCH)ColumbusOhio43205
Taha Akbar, BS
[email protected]
614-355-4526
Sara Mansfield, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital Los Angeles (CHLA)· Los Angeles, CALucile Packard Children's Hospital Stanford· Palo Alto, CAUniversity of Michigan· Ann Arbor, MINationwide Children's (NCH)· Columbus, OH

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