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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01099462
Enrollment
30
Registered
2010-04-07
Start date
2007-06-30
Completion date
2011-06-30
Last updated
2010-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever

Keywords

fever, Ibuprofen

Brief summary

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.

Interventions

DRUGIbuprofen

Ibuprofen (10mg/kg BW) will be given orally if the temperature on presentation is higher than 38.0OC according to the decision of the attending physician.

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Ibuprofen concentration in the CSF30 - 360 minutes after administration

Countries

Israel

Contacts

Primary ContactEran Kozer, MD
erank@asaf.health.gov.il97289779916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026