Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fever |
Drug: Ibuprofen |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- Ibuprofen concentration in the CSF [ Time Frame: 30 - 360 minutes after administration ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Whole blood CSF
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 3 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
children and Infants 3 month to 18 years of age with fever (rectal temperature >38.0OC or oral temperature > 37.6 OC)
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
Contacts and Locations| Contact: Eran Kozer, MD | 97289779916 | erank@asaf.health.gov.il |
| Israel | |
| Assaf Harofeh | Recruiting |
| Zerifin, Israel, 70300 | |
| Contact: Eran Kozer, MD 97289779916 erank@asaf.health.gov.il | |
| Principal Investigator: Eran Kozer, MD | |
More Information
No publications provided
| Responsible Party: | Eran Kozer, Assaf harofeh Medical center |
| ClinicalTrials.gov Identifier: | NCT01099462 History of Changes |
| Other Study ID Numbers: | 199/07*3 |
| Study First Received: | April 6, 2010 |
| Last Updated: | April 6, 2010 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Assaf-Harofeh Medical Center:
|
fever Ibuprofen |
Additional relevant MeSH terms:
|
Fever Body Temperature Changes Signs and Symptoms Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013