Effect of paracetamol (acetaminophen) on body temperature in acute ischemic stroke - A double-blind, randomized phase II clinical trial

Background and Purpose-Body temperature is a strong predictor of outcome in acute stroke. However, it is unknown whether antipyretic treatment leads t o early and clinically worthwhile reduction of body temperature in patients with acute stroke, especially when they have no fever. The main purpose of this trial was to study whether early treatment of acute ischemic stroke p atients with acetaminophen (paracetamol) reduces body temperature. Methods-Seventy-five patients with acute ischemic stroke confined to the an terior circulation were randomized to treatment with either 500 mg (low dos e) or 1000 mg (high dose) acetaminophen or with placebo, administered as su ppositories 6 times daily during 5 days. Body temperatures were measured wi th a rectal electronic thermometer at the start of treatment and after 24 h ours and with an infrared tympanic thermometer at 2-hour intervals during t he first 24 hours and at g-hour intervals thereafter. The primary outcome m easure was rectal temperature at 24 hours after the start of treatment. Results-Treatment with high-dose acetaminophen resulted in 0.4 degreesC low er body temperatures than placebo treatment at 24 hours (95% CI 0.1 degrees C to 0.7 degreesC). The mean reduction from baseline temperature with high- dose acetaminophen was 0.3 degreesC (95% CI 0 degreesC to 0.6 degreesC) hig her than that in placebo-treated patients. Treatment with low-dose acetamin ophen did not result in lower body temperatures. After 5 days of treatment, no differences in temperature were found between the placebo and the high- or low-dose acetaminophen groups. Conclusions-Treatment with a daily dose of 6000 mg acetaminophen may result in a small, but potentially beneficial, decrease in body temperature short ly after ischemic stroke, even in normothermic and subfebrile patients. Fur ther studies should determine whether this effect is reproducible and wheth er early reduction of body temperature leads to improved outcome.