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

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.

Study Overview

• Status: Unknown
• Conditions: Fever
• Intervention / Treatment: Drug: Ibuprofen

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Israel
  • Zerifin, Israel, 70300
    • Recruiting
    • Assaf Harofeh
    • Contact: Eran Kozer, MD; Phone Number: 97289779916; Email: erank@asaf.health.gov.il
    • Principal Investigator: Eran Kozer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children and Infants 3 month to 18 years of age with fever (rectal temperature >38.0OC or oral temperature > 37.6 OC)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with fever	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ibuprofen concentration in the CSF	30 - 360 minutes after administration

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Publications and helpful links

General Publications

• Har-Even R, Stepensky D, Britzi M, Soback S, Chaim AB, Brandriss N, Goldman M, Berkovitch M, Kozer E. Plasma and cerebrospinal fluid concentrations of ibuprofen in pediatric patients and antipyretic effect: Pharmacokinetic-pharmacodynamic modeling analysis. J Clin Pharmacol. 2014 Sep;54(9):1023-30. doi: 10.1002/jcph.307. Epub 2014 Apr 21.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 6, 2010
• First Posted (Estimate): April 7, 2010

Study Record Updates

• Last Update Posted (Estimate): April 7, 2010
• Last Update Submitted That Met QC Criteria: April 6, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: fever; Ibuprofen
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 199/07*3