Research article

Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690]

Diederik WJ Dippel^1* , Eric J van Breda^1* , H Bart van der Worp^2* , H Maarten A van Gemert^3* , Ron J Meijer^1* , L Jaap Kappelle^2* and Peter J Koudstaal^1* for the PISA-investigators.

¹  Department of Neurology, Erasmus Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands

²  Department of Neurology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands

³  Department of Neurology, Meander Medical Center, PO Box 1502 3800 BM Amersfoort, The Netherlands

author email corresponding author email* Contributed equally

BMC Cardiovascular Disorders 2003, 3:2doi:10.1186/1471-2261-3-2

Published:	6 February 2003

Abstract

Background

Body temperature is a strong predictor of outcome in acute stroke. In a previous randomized trial we observed that treatment with high-dose acetaminophen (paracetamol) led to a reduction of body temperature in patients with acute ischemic stroke, even when they had no fever. The purpose of the present trial was to study whether this effect of acetaminophen could be reproduced, and whether ibuprofen would have a similar, or even stronger effect.

Methods

Seventy-five patients with acute ischemic stroke confined to the anterior circulation were randomized to treatment with either 1000 mg acetaminophen, 400 mg ibuprofen, or placebo, given 6 times daily during 5 days. Treatment was started within 24 hours from the onset of symptoms. Body temperatures were measured at 2-hour intervals during the first 24 hours, and at 6-hour intervals thereafter.

Results

No difference in body temperature at 24 hours was observed between the three treatment groups. However, treatment with high-dose acetaminophen resulted in a 0.3°C larger reduction in body temperature from baseline than placebo treatment (95% CI: 0.0 to 0.6 °C). Acetaminophen had no significant effect on body temperature during the subsequent four days compared to placebo, and ibuprofen had no statistically significant effect on body temperature during the entire study period.

Conclusions

Treatment with a daily dose of 6000 mg acetaminophen results in a small, but potentially worthwhile decrease in body temperature after acute ischemic stroke, even in normothermic and subfebrile patients. Further large randomized clinical trials are needed to study whether early reduction of body temperature leads to improved outcome.