Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Fever

Treatments: Drug: Ibuprofen

Study type: Observational

Funder types: Other

Identifiers

NCT01099462

199/07*3

Details and patient eligibility

About

Ibuprofen, the active ingredient in Nurofen and Advil, is a commonly used drug in children. There is very limited data about Ibuprofen concentrations in the cerebro spinal fluid (CSF). The objective of the current study is to describe concentrations of ibuprofen in the CSF of infants and children after administration of ibuprofen. We will study infants presenting to the Emergency Department (ED) with fever who received ibuprofen. A complete sepsis workup including sampling of blood and CSF is conducted in cases of suspected meningitis. We will measure ibuprofen in the blood and CSF obtained during the sepsis workup. A better understanding of the pharmacokinetics of ibuprofen and its penetration into the CSF will unable us to suggest more accurate dosing guidelines, and to better predict the effects of this commonly used drug.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 3 month-18 years
• Rectal temperature > 38.0OC or oral temperature > 37.6 OC measured in the ED or at home.
• A sepsis work up is indicated
• At least one dose of Ibuprofen was given in the last 8 hours prior to lumbar puncture (LP)

Exclusion criteria

• Hypersensitivity to Ibuprofen
• Known metabolic disorder
• Known liver or kidney disease
• Hydrocephalus
• Informed consent could not be obtained from a legal guardian

Trial design

30 participants in 1 patient group

Children with fever

Treatment:

Drug: Ibuprofen