Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
up to 6 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < six (6) months of age.
Have a clinical indication of pain or fever.
Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures.
Have inadequate intravenous access.
Have an uncorrected ductus dependent congenital heart disease.
Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin.
Have a current history of uncorrected hypovolemia or acute renal disease.
Have a current history of acute liver disease.
Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to dosing. Have received another investigational drug within the past 30 days.
Be otherwise unsuitable for the study, in the opinion of the Investigator.