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PISA. The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: Protocol for a phase II double-blind randomised placebo-controlled trial [ISRCTN98608690]

DOI: 10.1186/1471-2261-2-7

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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 × 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.During the first days after stroke, between one and two fifths of the patients develop fever or subfebrile temperatures. [1-4] Increased temperatures have been associated with relatively large infarct volumes, high case fatality, and poor functional outcome, even after adjustment for initial stroke severity. [2-6] 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 harmful effects of an early rise in body temperature have been attributed to increased cerebral metabolic demands, [8] changes in the blood-brain barrier permeability, acidosis, and an increased release of excitatory amino acids. [9] In animal models of temporary focal cerebral ischemia, mild intra-ischaemic hyperthermia increased infarct volume, [10] whereas mild hypothermia reduced infarct size. [11]The above suggests that a pharmacological reduction of temperature in patients with acute ischaemic stroke may improve their functional outcome. Previously, we studied the effect


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