Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

PHASE4RecruitingINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

December 11, 2024

Primary Completion Date

October 16, 2026

Study Completion Date

October 31, 2027

Conditions
SurgeryPain, Post Operative
Interventions
DRUG

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)"

DRUG

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"

DRUG

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)

DRUG

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)

Trial Locations (4)

43205

RECRUITING

Nationwide Children's (NCH), Columbus

48109

RECRUITING

University of Michigan, Ann Arbor

90027

RECRUITING

Children's Hospital Los Angeles (CHLA), Los Angeles

94304

RECRUITING

Lucile Packard Children's Hospital Stanford, Palo Alto

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

University of Michigan

OTHER