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Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma

Primary Purpose

Asthma in Children

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Nebulized Magnesium sulfate
Intravenous magnesium sulphate
Sponsored by
Saima Khatoon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children focused on measuring asthma in children, intravenous magnesium sulphate, nebulized magnesium sulphate

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King edward medical university/mayo hospital lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nebulized magnesium sulphate

Intravenous magnesium sulphate

Arm Description

100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer

Magnesium sulphate according to weight will be given intravenously.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

duration of ICU stay
this will be measured in hours
duration of hospital stay
this will be measured in hours

Full Information

First Posted
July 16, 2020
Last Updated
February 19, 2021
Sponsor
Saima Khatoon
Collaborators
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04497766
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Saima Khatoon
Collaborators
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
asthma in children, intravenous magnesium sulphate, nebulized magnesium sulphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nebulized magnesium sulphate
Arm Type
Experimental
Arm Description
100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer
Arm Title
Intravenous magnesium sulphate
Arm Type
Experimental
Arm Description
Magnesium sulphate according to weight will be given intravenously.
Intervention Type
Drug
Intervention Name(s)
Nebulized Magnesium sulfate
Other Intervention Name(s)
Nebulized MgSO4
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Intravenous magnesium sulphate
Other Intervention Name(s)
IV MgSO4
Intervention Description
pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour
Primary Outcome Measure Information:
Title
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.
Description
The intervention will be considered effective if there is a drop of at least 4 points in PAS score at hour-6 of intervention.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
duration of ICU stay
Description
this will be measured in hours
Time Frame
72 hours/3 days
Title
duration of hospital stay
Description
this will be measured in hours
Time Frame
120 hours/5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad-Haroon Hamid, MBBS,FCPS,FRCP
Organizational Affiliation
chairman /Head of department of pediatrics unit1 K.E medical university/mayo hospital l
Official's Role
Principal Investigator
Facility Information:
Facility Name
King edward medical university/mayo hospital lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
56000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared after publication on a reasonable request.
Citations:
PubMed Identifier
24429155
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. Erratum In: Lancet Respir Med. 2013 Jun;1(4):285.
Results Reference
background
PubMed Identifier
25024668
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.
Results Reference
background
PubMed Identifier
24429154
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.
Results Reference
background
PubMed Identifier
25164315
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.
Results Reference
background
PubMed Identifier
23290189
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.
Results Reference
background
PubMed Identifier
25652104
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.
Results Reference
background
PubMed Identifier
24345031
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.
Results Reference
background
PubMed Identifier
27996280
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.
Results Reference
background
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/24429155/
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/25024668
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/24429154/
Description
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
URL
http://pubmed.ncbi.nlm.nih.gov/25164315/
Description
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
URL
http://pubmed.ncbi.nlm.nih.gov/23290189/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/25652104/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/24345031/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/27996280/
Description
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-

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Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma

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