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The3MgTrialRandomisedcontrolledtrialofintravenousor.doc

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The3MgTrialRandomisedcontrolledtrialofintravenousor.doc

The 3Mg Trial: Randomised controlled trial of intravenous or nebulised magnesium sulphate or standard therapy for severe acute asthma Steve Goodacre PhD1, Judith Cohen PhD1, Mike Bradburn MSc1, Alasdair Gray MD2, Jonathan Benger MD3, Timothy Coats MD4 on behalf of the 3Mg Research Team 1School of Health and Related Research (ScHARR), University of Sheffield, 2Emergency Department, Royal Infirmary of Edinburgh, 3Faculty of Health and Life Sciences, University of the West of England, Bristol, 4Emergency Department, Leicester Royal Infirmary Corresponding author Steve Goodacre, Professor of Emergency Medicine University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA Email: s.goodacre@sheffield.ac.uk Tel: +44 114 222 0842 This is the accepted version of an article that has been published in the Lancet Respiratory Medicine: /journals/lanres/article/PIIS2213-2600(13)70070-5/fulltext Registration: /ISRCT Lancet protocol 08PRT/503: /protocol-reviews/08PRT-503 Abstract Background: Previous studies suggest that intravenous (IV) or nebulised magnesium sulphate may improve respiratory function in acute asthma. We aimed to determine whether IV or nebulised magnesium sulphate improve symptoms of breathlessness and reduce the need for hospital admission in adults with severe acute asthma. Methods: In a double-blind placebo-controlled trial undertaken in the emergency departments of 34 hospitals we randomised 1109 adults with severe acute asthma to receive either IV magnesium sulphate (2g over 20 minutes) or nebulised magnesium sulphate (3 x 500mg over one hour) alongside standard therapy including salbutamol, or standard therapy alone. Consented participants were allocated to numbered treatment packs using a telephone or internet randomisation system. A simple randomisation sequence was used in 20 hospitals participating at the outset, but switched to blocked randomisation, stratified by hospital, for subsequent hospitals. Each treatment p

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