• Inger R de Ridder, Heleen M den Hertog, H Maarten A van Gemert, A H C M L Tobien Schreuder, Annemieke Ruitenberg, E Lisette Maasland, Ritu Saxena, Jordie H van Tuijl, Ben P W Jansen, Renske M Van den Berg-Vos, Frederique Vermeij, Peter J Koudstaal, L Jaap Kappelle, Ale Algra, H Bart van der Worp, Diederik W J Dippel, and Trial Organization.
• From the Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands (I.R.d.R., P.J.K., D.W.J.D.); Department of Neurology, Medical Spectrum Twente, Enschede, The Netherlands (H.M.d.H.); Department of Neurology, Meander Medical Center, Amersfoort, The Netherlands (H.M.A.v.G.); Department of Neurology, Zuyderland Medical Center, Heerlen, The Netherlands (A.H.C.M.L.T.S.); Department of Neurology, Admiraal de Ruyter Hospital, Goes, The Netherlands (A.R.); Department of Neurology, Van Weel-Bethesda Hospital, Dirksland, The Netherlands (E.L.M.); Department of Neurology, Maasstad Hospital, Rotterdam, The Netherlands (R.S.); Department of Neurology, Elisabeth Twee Steden Hospital, Tilburg, The Netherlands (J.H.v.T., B.P.W.J.); Department of Neurology, OLVG location West, Amsterdam, The Netherlands (R.M.V.d.B.-V.); Department of Neurology, Franciscus Gasthuis, Rotterdam, The Netherlands (F.V.); Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, The Netherlands (L.J.K., A.A., H.B.v.d.W.); and Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands (A.A.). i.deridder@erasmusmc.nl.
• Stroke. 2017 Apr 1; 48 (4): 977-982.

Background And PurposeSubfebrile body temperature and fever in the first days after stroke are strongly associated with unfavorable outcome. A subgroup analysis of a previous trial suggested that early treatment with paracetamol may improve functional outcome in patients with acute stroke and a body temperature of ≥36.5°C. In the present trial, we aimed to confirm this finding.MethodsPAIS 2 (Paracetamol [Acetaminophen] in Stroke 2) was a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aimed to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients were treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome was functional outcome at 3 months, assessed with the modified Rankin Scale and analyzed with multivariable ordinal logistic regression. Because of slow recruitment and lack of funding, the study was stopped prematurely.ResultsBetween December 2011 and October 2015, we included 256 patients, of whom 136 (53%) were allocated to paracetamol. In this small sample, paracetamol had no effect on functional outcome (adjusted common odds ratio, 1.15; 95% confidence interval, 0.74-1.79). There was no difference in the number of serious adverse events (paracetamol n=35 [26%] versus placebo n=28 [24%]).ConclusionsTreatment with high-dose paracetamol seemed to be safe. The effect of high-dose paracetamol on functional outcome remains uncertain. Therefore, a large trial of early treatment with high-dose paracetamol is still needed.Clinical Trial RegistrationURL: http://www.trialregister.nl. Unique identifier: NTR2365.© 2017 American Heart Association, Inc.

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