Paracetamol (Acetaminophen) in stroke 2 (PAIS 2): Protocol for a randomized, placebo-controlled, double-blind clinical trial to assess the effect of high-dose paracetamol on functional outcome in patients with acute stroke and a body temperature of 36.5 degrees C or above

摘要

RationaleIn the first hours after stroke onset, subfebrile temperatures and fever have been associated with poor functional outcome. In the first Paracetamol (Acetaminophen) in Stroke trial, a randomized clinical trial of 1400 patients with acute stroke, patients who were treated with high-dose paracetamol showed more improvement on the modified Rankin Scale at three-months than patients treated with placebo, but this difference was not statistically significant. In the 661 patients with a baseline body temperature of 370 degrees C or above, treatment with paracetamol increased the odds of functional improvement (odds ratio 143; 95% confidence interval: 102-197). This relation was also found in the patients with a body temperature of 365 degrees C or higher (odds ratio 131; 95% confidence interval 101-168). These findings need confirmation.