900
Participants
Start Date
December 11, 2024
Primary Completion Date
October 16, 2026
Study Completion Date
October 31, 2027
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)
RECRUITING
Nationwide Children's (NCH), Columbus
RECRUITING
University of Michigan, Ann Arbor
RECRUITING
Children's Hospital Los Angeles (CHLA), Los Angeles
RECRUITING
Lucile Packard Children's Hospital Stanford, Palo Alto
Patient-Centered Outcomes Research Institute
OTHER
University of Michigan
OTHER