Last updated on July 2019

Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Pain Service | Pain | Fever
  • Age: - 1 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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