Fever Clinical Trial - Acetaminophen Concentration in Cerebrospinal Fluid

Status Completed

Clinical Trial Summary

Acetaminophen is the most commonly used drug in children. Inhibition of COX-3 in the brain has been suggested as the primary central mechanism by which acetaminophen decrease pain and possibly fever. However there is very limited data about acetaminophen concentrations in the brain and no such data is available for newborns. The objective of the current study is to describe concentrations of acetaminophen in the fluid around the brain of infants after administration of acetaminophen.

Clinical Trial Description

The mechanism by which acetaminophen causes analgesia and antipyretic effect is not entirely clear. Recently a new COX isoenzyme was identified and termed COX 3. In humans this isoenzyme is most abundant in cerebral cortex and heart. Inhibition of COX-3 could represent a primary central mechanism by which acetaminophen decrease pain and possibly fever (10). An effect on of acetaminophen on presynaptic 5-HT(2) receptors in the hypocampus has been demonstrated (11) suggesting again that the primary effect of acetaminophen is in the CNS.

Many studies (12-16) described the pharmacokinetics of oral and rectal acetaminophen in infants and neonates. Yet, the data on acetaminophen concentrations in the CSF is very limited. Two studies in adults (17;18) used intravenous propacetamol and described concentrations of acetaminophen in the plasma and CSF. Acetaminophen was detected as early as 15 minutes after the administration and reached peak concentrations in the CSF at the 4th hour. A small study (19) of nine children who had indwelling ventricular drains found that cerebrospinal fluid concentrations lagged behind those of plasma with an equilibration half time of 0.72 h. This study did not describe CSF concentrations in neonates and used a dose of 40mg/kg, which is higher than the recommended dose in children. To the best of our knowledge there is no data on acetaminophen CSF concentrations in neonates.

The objective of the current study is to describe concentrations of acetaminophen in the CSF of infants after single administration of acetaminophen. A better understanding of the pharmacokinetics of acetaminophen and its penetration into the CSF will enable us to better predict the effects of this commonly used drug. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Fever

Clinical Trial Details

NCT number	NCT00389454
Study type	Observational
Source	Assaf-Harofeh Medical Center
Contact
Status	Completed
Phase	N/A
Start date	January 2004
Completion date	June 2007

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Acetaminophen Concentration in Cerebrospinal Fluid in Infants

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms