Clinical trial NCT04497766: Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma
Official title: Comparasion of Efficacy of Nebulized Magnesium Sulphate With Intravenous Magnesium Sulphate in Children With Acute Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma in Children
Keywords: asthma in children
intravenous magnesium sulphate
nebulized magnesium sulphate
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
Collaborators: name: King Edward Medical University
First posted: 2020-08-04
Enrollment: 148
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in children presenting with acute asthma.Study perfoma consists of demographic variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2 at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.

Detailed description: After getting informed consent from guardian,148 patients of acute moderate ro severe asthma with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will receive nebulization with magnesium sulphate and other will receive intravenous magnesium sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in either groups after 6 hours.

Eligibility criteria: Inclusion Criteria:

* patients with age 2 to 12 years with acute moderate to severe exacerbation of asthma as per operational definition children who are unrespoinsive to standard treatment of asthma at 60 minutes

Exclusion Criteria:

* those with history of chronic lung disease and abnormal renal function contraindication for MgSO4 due to hepatic or renal disease allergy to MgSo4 children who has other comorbid illness

Primary outcomes:
measure: Efficacy of nebulized magnesium sulphate with intravenous magnesium sulphate in children with acute asthma will be assessed by a drop in PAS score, as assessed at 6 hours of intervention.
timeFrame: 6 hours
Secondary outcomes:
measure: duration of ICU stay
timeFrame: 72 hours/3 days
measure: duration of hospital stay
timeFrame: 120 hours/5 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King edward medical university/mayo hospital lahore
state: Punjab
Study officials:
affiliation: chairman /Head of department of pediatrics unit1 K.E medical university/mayo hospital l
name: Muhammad-Haroon Hamid, MBBS,FCPS,FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Powell C, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson P; MAGNETIC study group. Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. Lancet Respir Med. 2013 Jun;1(4):301-8. doi: 10.1016/S2213-2600(13)70037-7. Epub 2013 Apr 22.
citation: Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients. J Pediatr Pharmacol Ther. 2014 Apr;19(2):91-7. doi: 10.5863/1551-6776-19.2.91.
citation: Goodacre S, Cohen J, Bradburn M, Gray A, Benger J, Coats T; 3Mg Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Jun;1(4):293-300. doi: 10.1016/S2213-2600(13)70070-5. Epub 2013 May 17.
citation: Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Paediatr. 2014 Dec;103(12):1301-6. doi: 10.1111/apa.12780. Epub 2014 Oct 2.
citation: Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J, Liu L. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respir Med. 2013 Mar;107(3):321-30. doi: 10.1016/j.rmed.2012.12.001. Epub 2013 Jan 3.
citation: Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.
citation: Albuali WH. The use of intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1809-15. doi: 10.3109/14767058.2013.876620. Epub 2014 Jan 30.
citation: Daengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac J Allergy Immunol. 2017 Jun;35(2):108-112. doi: 10.12932/AP0780.