Abstract
During the first days after stroke, one to two fifths of the patients develop fever or subfebrile temperatures. Body temperature is a strong prognostic factor after stroke. Pharmacological reduction of temperature in patients with acute ischaemic stroke may improve their functional outcome. Previously, we studied the effect of high dose (6 g daily) and low dose (3 g daily) paracetamol (acetaminophen) in a randomised placebo-controlled trial of 75 patients with acute ischemic stroke. In the high-dose paracetamol group, mean body temperature at 12 and 24 hours after start of treatment was 0.4 degrees C lower than in the placebo group. The effect of ibuprofen, another potent antipyretic drug, on body-core temperature in normothermic patients has not been studied. The aim of the present trial is to study the effects of high-dose paracetamol and ibuprofen on body temperature in patients with acute ischaemic stroke, and to study the safety of these treatments. Seventy-five (3 x 25) patients with acute ischaemic stroke confined to the anterior circulation will be randomised to treatment with either: 400 mg ibuprofen, 1000 mg acetaminophen, or with placebo 6 times daily during 5 days. Body-temperatures will be measured with a rectal electronic thermometer at the start of treatment and after 24 hours. An infrared tympanic thermometer will be used to monitor body temperature at 2-hour intervals during the first 24 hours and at 12-hour intervals thereafter. The primary outcome measure will be rectal temperature at 24 hours after the start of treatment. The study results will be analysed on an intent-to-treat basis, but an on-treatment analysis will also be performed. No formal interim analysis will be carried out.
Highlights
During the first days after stroke, one to two fifths of the patients develop fever or subfebrile temperatures
During the first days after stroke, between one and two fifths of the patients develop fever or subfebrile temperatures. [1,2,3,4] Increased temperatures have been associated with relatively large infarct volumes, high case fatality, and poor functional outcome, even after adjustment for initial stroke severity. [2,3,4,5,6] The period in which hyperthermia is associated with poor outcome is probably limited to the first 12 or 24 hours from stroke onset. [6,7]
The above suggests that a pharmacological reduction of temperature in patients with acute ischaemic stroke may improve their functional outcome
Summary
During the first days after stroke, one to two fifths of the patients develop fever or subfebrile temperatures. Pharmacological reduction of temperature in patients with acute ischaemic stroke may improve their functional outcome. We studied the effect of high dose (6 g daily) and low dose (3 g daily) paracetamol (acetaminophen) in a randomised placebo-controlled trial of 75 patients with acute ischemic stroke. We studied the effect on body temperature of high (6 g daily) and medium dose (3 g daily) paracetamol (acetaminophen) in a randomised placebo controlled trial of 3 × 25 patients (PAPAS: paracetamol (acetaminophen) in patients with acute stroke). Koennecke conducted a comparable study of 40 patients with acute stroke He showed that treatment with paracetamol in a daily dose of 4000 mg resulted in a substantial reduction of the proportion of patients with body temperatures over 37.5°C, but he did not estimate the size of the temperature reduction. It is usually well tolerated, has almost no side effects or drug interactions at therapeutic doses, and it affects the platelet aggregation in doses of more than 1 g by reversible inhibition of cyclo-oxygenase
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