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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparasion of Efficacy of Nebulized Magnesium Sulphate With Intravenous Magnesium Sulphate in Children With Acute Asthma

Conditions
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Asthma in Children

Intervention / Treatment
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* Drug: Nebulized Magnesium sulfate
* Drug: Intravenous magnesium sulphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized magnesium sulphate<br>100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer | Drug: Nebulized Magnesium sulfate<br>* 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<br>* Other names: Nebulized MgSO4;|
| Experimental: Intravenous magnesium sulphate<br>Magnesium sulphate according to weight will be given intravenously. | Drug: Intravenous magnesium sulphate<br>* pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour<br>* Other names: IV MgSO4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of ICU stay | this will be measured in hours | 72 hours/3 days | 
| duration of hospital stay | this will be measured in hours | 120 hours/5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma in children, intravenous magnesium sulphate, nebulized magnesium sulphate