Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
NCT ID: NCT06671002
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
900 participants
INTERVENTIONAL
2024-12-11
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acetaminophen/NSAID regimen
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)
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)
Acetaminophen/NSAID/Opioid regimen
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergo one the following: elective tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).
Exclusion Criteria
* 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)
12 Years
20 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Michigan
OTHER
Responsible Party
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Mark Bicket, MD, PhD
Associate Professor of Anesthesiology
Principal Investigators
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Mark Bicket, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Children's Hospital Los Angeles (CHLA)
Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
University of Michigan
Ann Arbor, Michigan, United States
Nationwide Children's (NCH)
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Other Identifiers
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BPS-2023C1-32147
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HUM00252793
Identifier Type: -
Identifier Source: org_study_id
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