NCT00389454

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

October 31, 2007

Status Verified

August 1, 2006

First QC Date

October 17, 2006

Last Update Submit

October 30, 2007

Conditions

Fever

Keywords

AcetaminophenFevercerebro spinal fluidInfants

Eligibility Criteria

Age1 Week - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Emergency Unit Assaf Harofeh Medical center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eran Kozer, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

January 1, 2004

Study Completion

June 1, 2007

Last Updated

October 31, 2007

Record last verified: 2006-08

Locations

IL(1)