Acetaminophen for Altering Body Temperature in Acute Stroke
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Status:
Trial complete. Results published January 2002.
Purpose:
To assess the efficacy of regularly administered acetaminophen in modifying core body temperature of awake, afebrile acute stroke patients over 24 hours.
Interventions:
Acetaminophen
Anti-pyretic analgesic; potent inhibitor of hemoprotein-catalyzed lipid peroxidatrion with an IC50 for hemoglovin of 15uM, which is in the range of plasma levels resulting from therapeutic doses of the drug in humans. It acts by reducing the ferryl-oxo radical form of the heme, and thereby prevents formation of the hemoprotein radical that initiates lipid peroxidation.
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Location(s):
University of Pennsylvania
University of Texas-Houston
Year Started:
1997
Year Finished:
2001
Design:
Randomized controlled clinical trial with 39 patients at 2 university hospitals.
Inclusion Criteria
Patients presenting with evidence of acute ischemic stroke or hemorrhagic stroke within 24 hours, NIHSS score greater than or equl to 5, core body temperature less than 38.5 degrees C, white blood cell count less then 12.6x10 (3) cells/mm(3).
Exclusion Criteria
Clinical or radiological signs of infection, severe medical illnesses, known contraindication or hypersensitivity to acetaminophen, known contraindication to placement of a urinary catheter, or participation in another interventional clinical trial for acute stroke.
Patient Involvement:
Patients received either acetaminophen 650 mg or placebo every 4 hours for 24 hours (7 doses, 4550 mg total). Core body temperature was measured every 30 minutes via temperature-sensing catheter in the urinary bladder.
Primary Outcome:
Mean core body temperature during the 24 hour study.
Secondary Outcome:
Change in NIHSS.
Results:
Early administration of 650 mg acetaminophen every 4 hours did not result in a statistically significant reduction in core body temperature.
Source of Information:
Stroke. 2002;33:130-135.
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This information last updated on: 5/2/2003
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