Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma
1 other identifier
interventional
148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedFebruary 23, 2021
February 1, 2021
1 year
July 16, 2020
February 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
The intervention will be considered effective if there is a drop of at least 4 points in PAS score at hour-6 of intervention.
6 hours
Secondary Outcomes (2)
duration of ICU stay
72 hours/3 days
duration of hospital stay
120 hours/5 days
Study Arms (2)
Nebulized magnesium sulphate
EXPERIMENTAL100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer
Intravenous magnesium sulphate
EXPERIMENTALMagnesium sulphate according to weight will be given intravenously.
Interventions
MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes
pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Saima Khatoonlead
- King Edward Medical Universitycollaborator
Study Sites (1)
King edward medical university/mayo hospital lahore
Lahore, Punjab Province, 56000, Pakistan
Related Publications (8)
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.
PMID: 24429155BACKGROUNDKokotajlo 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.
PMID: 25024668BACKGROUNDGoodacre 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.
PMID: 24429154BACKGROUNDSinghi 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.
PMID: 25164315BACKGROUNDShan 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.
PMID: 23290189BACKGROUNDAlansari 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.
PMID: 25652104BACKGROUNDAlbuali 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.
PMID: 24345031BACKGROUNDDaengsuwan 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.
PMID: 27996280BACKGROUND
Related Links
- Powell C, Dona RK, Lowe, J, Boland A, Petrou S, Doull I, et al. Magnesium sulphate in acute sever asthma in children (MAGNETIC): a randomized, placebo-controlled trial. The Lancet Respiratory Medicine. 2013;1(4):301-8.
- 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;19(2) :91-7.
- Goodacre S, Cohen J, 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;1(4
- Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Peadiatrica. 2014;103(12):1301-6
- Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J,et al. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respiratory medicine. 2013;107(3):321-30.
- Alansari K, Ahmed W, Davidson B, Alamri M, Zakaria I, Alrifaari M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized tria.Pediatr Pumonol 2015;50(12):1191-9.
- Albuali WH. The Use of Intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal.2014;27(17):1809-15.
- aengsuwan 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/allergy immunol. 2016; 35(2):108-
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad-Haroon Hamid, MBBS,FCPS,FRCP
chairman /Head of department of pediatrics unit1 K.E medical university/mayo hospital l
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Post Graduate Resident in Pediatrics (MD Paeds)
Study Record Dates
First Submitted
July 16, 2020
First Posted
August 4, 2020
Study Start
October 1, 2019
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
Data will be shared after publication on a reasonable request.