PMID- 24429155 OWN - NLM STAT- MEDLINE DCOM- 20140220 LR - 20140815 IS - 2213-2600 (Print) IS - 2213-2600 (Linking) VI - 1 IP - 4 DP - 2013 Jun TI - Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. PG - 301-8 LID - S2213-2600(13)70037-7 [pii] LID - 10.1016/S2213-2600(13)70037-7 [doi] AB - BACKGROUND: Little evidence is available for the effect of nebulised magnesium sulphate (MgSO(4)) in acute asthma in children. We assessed the effect of MgSO(4) treatment in children with severe acute asthma. METHODS: In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2-16 years) with severe acute asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2.5 mL of isotonic MgSO(4) (250 mmol/L; 151 mg per dose; MgSO(4) group) or 2.5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p<0.05 for a between-group difference, but regarded a between-group difference in ASS of 0.5 as the minimal clinically significant treatment effect. Analysis was done by intention to treat. This trial is registered with controlled-trials.com, number ISRCTN81456894. FINDINGS: Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO(4) and 256 to placebo. Mean ASS at 60 min was lower in the MgSO(4) group (4.72 [SD 1.37]) than it was in the placebo group (4.95 [SD 1.40]; adjusted difference -0.25, 95% CI -0.48 to -0.02; p=0.03). This difference, however, was not clinically significant. The clinical effect was larger in children with more severe asthma exacerbation (p=0.03) and those with symptoms present for less than 6 h (p=0.049). We detected no difference in the occurrence of adverse events between groups. INTERPRETATION: Overall, nebulised isotonic MgSO(4), given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with acute severe asthma. However, the greatest clinical response was seen in children with more severe attacks (SaO(2)<92%) at presentation and those with preceding symptoms lasting less than 6 h. FUNDING: National Institute for Health Research Health Technology Assessment Programme. CI - Copyright (c) 2013 Elsevier Ltd. All rights reserved. FAU - Powell, Colin AU - Powell C AD - School of Medicine, Cardiff University, Cardiff, UK. Electronic address: powellc7@cardiff.ac.uk. FAU - Kolamunnage-Dona, Ruwanthi AU - Kolamunnage-Dona R AD - Department of Biostatistics, University of Liverpool, Liverpool, UK. FAU - Lowe, John AU - Lowe J AD - School of Medicine, Cardiff University, Cardiff, UK; Department of Biostatistics, University of Liverpool, Liverpool, UK. FAU - Boland, Angela AU - Boland A AD - Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK. FAU - Petrou, Stavros AU - Petrou S AD - Department of Public Health, University of Warwick, Coventry, UK. FAU - Doull, Iolo AU - Doull I AD - Department of Respiratory Paediatrics, Children's Hospital for Wales, Cardiff, UK. FAU - Hood, Kerenza AU - Hood K AD - School of Medicine, Cardiff University, Cardiff, UK. FAU - Williamson, Paula AU - Williamson P AD - Department of Biostatistics, University of Liverpool, Liverpool, UK. CN - MAGNETIC study group LA - eng SI - ISRCTN/ISRCTN81456894 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130422 PL - England TA - Lancet Respir Med JT - The Lancet. Respiratory medicine JID - 101605555 RN - 0 (Anticonvulsants) RN - 0 (Bronchodilator Agents) RN - 7487-88-9 (Magnesium Sulfate) RN - GR88G0I6UL (Ipratropium) RN - QF8SVZ843E (Albuterol) SB - IM EIN - Lancet Respir Med. 2013 Jun;1(4):285 MH - Acute Disease MH - Administration, Inhalation MH - Adolescent MH - Albuterol/administration & dosage MH - Anticonvulsants/administration & dosage MH - Asthma/diagnosis/*drug therapy/physiopathology MH - Bronchodilator Agents/administration & dosage MH - Child MH - Child, Preschool MH - Drug Therapy, Combination MH - Female MH - Follow-Up Studies MH - Forced Expiratory Volume/drug effects/*physiology MH - Humans MH - Injections, Intravenous MH - Ipratropium/administration & dosage MH - Magnesium Sulfate/*administration & dosage MH - Male MH - Respiratory Muscles/drug effects/*physiopathology MH - Retrospective Studies MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2014/01/17 06:00 MHDA- 2014/02/22 06:00 CRDT- 2014/01/17 06:00 PHST- 2014/01/17 06:00 [entrez] PHST- 2014/01/17 06:00 [pubmed] PHST- 2014/02/22 06:00 [medline] AID - S2213-2600(13)70037-7 [pii] AID - 10.1016/S2213-2600(13)70037-7 [doi] PST - ppublish SO - Lancet Respir Med. 2013 Jun;1(4):301-8. doi: 10.1016/S2213-2600(13)70037-7. Epub 2013 Apr 22.