rdf:type |
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lifeskim:mentions |
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pubmed:dateCreated |
2003-10-29
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pubmed:databankReference |
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pubmed:abstractText |
BACKGROUND: During the first days after stroke, one to two fifths of the patients develop fever or subfebrile temperatures. Body temperature is a strong prognostic factor after stroke. Pharmacological reduction of temperature in patients with acute ischaemic stroke may improve their functional outcome. Previously, we studied the effect of high dose (6 g daily) and low dose (3 g daily) paracetamol (acetaminophen) in a randomised placebo-controlled trial of 75 patients with acute ischemic stroke. In the high-dose paracetamol group, mean body temperature at 12 and 24 hours after start of treatment was 0.4 degrees C lower than in the placebo group. The effect of ibuprofen, another potent antipyretic drug, on body-core temperature in normothermic patients has not been studied. AIM: 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. DESIGN: Seventy-five (3 x 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.
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pubmed:commentsCorrections |
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-10234601,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-11441208,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-11756615,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-11779901,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-1251682,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-1447436,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-1621668,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-1876249,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-2568705,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-3363593,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-3552585,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-3951716,
http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-5485695,
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http://linkedlifedata.com/resource/pubmed/commentcorrection/11918829-9836750
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
Mar
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pubmed:issn |
1471-2261
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pubmed:author |
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pubmed:issnType |
Electronic
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pubmed:day |
27
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pubmed:volume |
2
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
7
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pubmed:dateRevised |
2009-11-18
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pubmed:meshHeading |
pubmed-meshheading:11918829-Acetaminophen,
pubmed-meshheading:11918829-Anti-Inflammatory Agents, Non-Steroidal,
pubmed-meshheading:11918829-Body Temperature,
pubmed-meshheading:11918829-Clinical Trials, Phase II as Topic,
pubmed-meshheading:11918829-Feasibility Studies,
pubmed-meshheading:11918829-Fever,
pubmed-meshheading:11918829-Humans,
pubmed-meshheading:11918829-Ibuprofen,
pubmed-meshheading:11918829-Randomized Controlled Trials as Topic,
pubmed-meshheading:11918829-Stroke
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pubmed:year |
2002
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pubmed:articleTitle |
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].
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pubmed:affiliation |
Department of Neurology, University Hospital Rotterdam, PO Box 2040, 3000 CA Rotterdam, The Netherlands. breda@neuro.fgg.eur.nl
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pubmed:publicationType |
Journal Article,
Research Support, Non-U.S. Gov't
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