644
Participants
Start Date
August 20, 2025
Primary Completion Date
July 31, 2029
Study Completion Date
August 31, 2029
Acetaminophen
"Intravenous (IV) dose, 15 mg/kg\* (maximum 600 mg) every 6 h for 5 days.~\*Note: For children \<28 days old, dose will be 12.5 mg/kg every 6 hours, as per U.S. Food and Drug Administration (FDA) recommendations. The dosing of acetaminophen for intravenous infusion will follow the current Acetaminophen for injection labeling based on the participant's age and weight."
Ketorolac
IV dose; 0.5mg/kg (maximum 30 mg) every 6 h for 5 days 4.1.d. \*Note: Ketorolac for intravenous bolus administration is currently labeled for multiple-dose treatment in adults. For patients under 65 years of age, the recommended dose is 30 mg every 6 hours, with a maximum daily dose of 120 mg. For patients 65 years or older, renally impaired patients, and those weighting less than 50 kg, the recommended dose is 15 mg every 6 hours, with a maximum daily dose of 60 mg. In this study, we will be limiting ketorolac to \<15 mg per dose, with a maximum of 60 mg per day.
Placebo
Placebos will be normal saline solution, i.e., 0.9% NaCl. In order to maintain blinding, the investigational pharmacy will dispense placebo in a volume to match the corresponding study drug.
NOT_YET_RECRUITING
Medical University of South Carolina, Charleston
NOT_YET_RECRUITING
Arkansas Children's Hospital, Little Rock
NOT_YET_RECRUITING
Children's National Hospital, Washington D.C.
NOT_YET_RECRUITING
University of Michigan, Ann Arbor
RECRUITING
Children's Hospital of Michigan, Detroit
NOT_YET_RECRUITING
University of Minnesota, Minneapolis
NOT_YET_RECRUITING
Duke Children's Hospital & Health Center, Durham
RECRUITING
Rainbow Babies and Children's Hospital, Cleveland
NOT_YET_RECRUITING
Nationwide Children's Hospital, Columbus
NOT_YET_RECRUITING
Penn State Health/Hershey Medical Center, Hershey
NOT_YET_RECRUITING
Children's Hospital of Philadelphia, Philadelphia
NOT_YET_RECRUITING
University of Pittsburgh, Pittsburgh
NOT_YET_RECRUITING
Texas Children's Hospital/Baylor College of Medicine, Houston
NOT_YET_RECRUITING
Primary Children's Medical Center, Salt Lake City
NOT_YET_RECRUITING
Wisconsin Children's, Milwaukee
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Weill Medical College of Cornell University
OTHER