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Open Access Study protocol

PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN 74418480]

Eric J van Breda1, H Bart van der Worp2, H Maarten A van Gemert3, Ale Algra2, L Jaap Kappelle2, Jan van Gijn2, Peter J Koudstaal1, Diederik WJ Dippel1* and the PAIS investigators

Author Affiliations

1 Erasmus Medical Center Rotterdam, the Netherlands

2 University Medical Center Utrecht, the Netherlands

3 Meander Medical Center, the Netherlands

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BMC Cardiovascular Disorders 2005, 5:24  doi:10.1186/1471-2261-5-24

Published: 19 August 2005

Abstract

Background

In patients with acute stroke, increased body temperature is associated with large lesion volumes, high case fatality, and poor functional outcome. A 1°C increase in body temperature may double the odds of poor outcome. Two randomized double-blind clinical trials in patients with acute ischemic stroke have shown that treatment with a daily dose of 6 g acetaminophen (paracetamol) results in a small but rapid and potentially worthwhile reduction of 0.3°C (95% CI: 0.1–0.5) in body temperature. We set out to test the hypothesis that early antipyretic therapy reduces the risk of death or dependency in patients with acute stroke, even if they are normothermic.

Methods/design

Paracetamol (Acetaminophen) In Stroke (PAIS) is a randomized, double-blind clinical trial, comparing high-dose acetaminophen with placebo in 2500 patients. Inclusion criteria are a clinical diagnosis of hemorrhagic or ischemic stroke and the possibility to start treatment within 12 hours from onset of symptoms. The study will have a power of 86% to detect an absolute difference of 6% in the risk of death or dependency at three months, and a power of 72% to detect an absolute difference of 5%, at a 5% significance level.

Discussion

This is a simple trial, with a drug that only has a small effect on body temperature in normothermic patients. However, when lowering body temperature with acetaminophen does have the expected effectiveness, 20 patients will have to be treated to prevent dependency or death in one.