Optimizing Pain Treatment in Children On Mechanical Ventilation

PHASE3RecruitingINTERVENTIONAL
Enrollment

644

Participants

Timeline

Start Date

August 20, 2025

Primary Completion Date

July 31, 2029

Study Completion Date

August 31, 2029

Conditions
Mechanical VentilationPediatric Acute Respiratory FailureAnalgesics, OpioidSedation and Analgesia
Interventions
DRUG

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."

DRUG

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.

DRUG

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.

Trial Locations (15)

29425

NOT_YET_RECRUITING

Medical University of South Carolina, Charleston

72202

NOT_YET_RECRUITING

Arkansas Children's Hospital, Little Rock

20010-2916

NOT_YET_RECRUITING

Children's National Hospital, Washington D.C.

48109-1274

NOT_YET_RECRUITING

University of Michigan, Ann Arbor

48201-2119

RECRUITING

Children's Hospital of Michigan, Detroit

55454-1450

NOT_YET_RECRUITING

University of Minnesota, Minneapolis

27705-4677

NOT_YET_RECRUITING

Duke Children's Hospital & Health Center, Durham

44106-4919

RECRUITING

Rainbow Babies and Children's Hospital, Cleveland

43205-2664

NOT_YET_RECRUITING

Nationwide Children's Hospital, Columbus

17033-0850

NOT_YET_RECRUITING

Penn State Health/Hershey Medical Center, Hershey

19104-4319

NOT_YET_RECRUITING

Children's Hospital of Philadelphia, Philadelphia

15261-0001

NOT_YET_RECRUITING

University of Pittsburgh, Pittsburgh

77030-3411

NOT_YET_RECRUITING

Texas Children's Hospital/Baylor College of Medicine, Houston

84112-9023

NOT_YET_RECRUITING

Primary Children's Medical Center, Salt Lake City

53226-3548

NOT_YET_RECRUITING

Wisconsin Children's, Milwaukee

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Weill Medical College of Cornell University

OTHER