Acetaminophen Concentration in Cerebrospinal Fluid in Infants

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.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 week–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Emergency Unit Assaf Harofeh Medical center

Ẕerifin, 70300, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age: 1week - 2 years
Rectal temperature > 38.0OC
A sepsis work up is indicated
Acetaminophen was given prior to lumbar puncture (LP)

Exclusion criteria

Hypersensitivity to acetaminophen
Known metabolic disorder
Known liver or kidney disease
Hydrocephalus
Informed consent could not be obtained from a legal guardian

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Important dates

Study start: 2004
Study completion: 2007
First posted: Oct 18, 2006
Registry last updated: Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed