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
| Autor: | Ritu Saxena, Ale Algra, Heleen M. den Hertog, Frank Jan de Jong, Diederik W.J. Dippel, Hester F. Lingsma, Peter J. Koudstaal, H. Maarten A. van Gemert, A. H C M L Tobien Schreuder, Inger R. de Ridder, Jordie H. van Tuijl, Annemieke Ruitenberg, L. Jaap Kappelle, E. Lisette Maasland, Peter Oomes, H. Bart van der Worp |
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| Přispěvatelé: | Neurology, Public Health |
| Rok vydání: | 2015 |
| Předmět: |
Male
Antipyretics Fever Placebo Body Temperature law.invention Clinical Protocols Double-Blind Method Randomized controlled trial law Modified Rankin Scale medicine Humans Multicenter Studies as Topic Stroke Acetaminophen Randomized Controlled Trials as Topic Intracerebral hemorrhage Dose-Response Relationship Drug business.industry digestive oral and skin physiology Odds ratio medicine.disease Clinical trial Neurology Anesthesia Female business medicine.drug |
| Zdroj: | International Journal of Stroke, 10(3), 457-462. SAGE Publications Ltd |
| ISSN: | 1747-4949 1747-4930 |
| Popis: | Rationale In 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 37·0°C or above, treatment with paracetamol increased the odds of functional improvement (odds ratio 1·43; 95% confidence interval: 1·02–1·97). This relation was also found in the patients with a body temperature of 36·5°C or higher (odds ratio 1·31; 95% confidence interval 1·01–1·68). These findings need confirmation. Aim The study aims to assess the effect of high-dose paracetamol in patients with acute stroke and a body temperature of 36·5°C or above on functional outcome. Design The Paracetamol (Acetaminophen) In Stroke 2 trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial. We use a power of 85% to detect a significant difference in the scores on the modified Rankin Scale of the paracetamol group compared with the placebo group at a level of significance of 0·05 and assume a treatment effect of 7%. Fifteen-hundred patients with acute ischemic stroke or intracerebral hemorrhage and a body temperature of 36·5°C or above will be included within 12 h of symptom onset. Patients will be treated with paracetamol in a daily dose of six-grams or matching placebo for three consecutive days. The Paracetamol (Acetaminophen) In Stroke 2 trial has been registered as NTR2365 in The Netherlands Trial Register. Study outcomes The primary outcome will be improvement on the modified Rankin Scale at three-months as analyzed by ordinal logistic regression. Discussion If high-dose paracetamol will be proven effective, a simple, safe, and extremely cheap therapy will be available for many patients with acute stroke worldwide. |
| Databáze: | OpenAIRE |
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