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

Fever Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01099462
• Other study ID #: 199/07*3
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2010
• Last updated: April 6, 2010
• Start date: June 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2010
• Source: Assaf-Harofeh Medical Center
• Contact: Eran Kozer, MD
• Phone: 97289779916
• Email: erank[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fever

Intervention

Drug:
• Ibuprofen
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.

Locations

Country	Name	City	State
Israel	Assaf Harofeh	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ibuprofen concentration in the CSF		30 - 360 minutes after administration	No