Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

Study Overview
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Brief Summary
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In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of clinical condition of the patient and length of hospital stay. There will be total 108 patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given Ventolin and Magnesium sulphate.

Detailed Description
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This randomized clinical trial will include 126 patients after taking informed consent who will meet the eligibility criteria. Patients will be randomly distributed in 2 groups on alternate basis as computerized generated number. Improvement will be assessed in terms of clinical condition i.e., Heart Rate, Respiratory Rate, blood pressure, pattern of breathing oxygen saturation and Pediatric Respiratory Assessment Measure (PRAM) score at start of treatment and then afterwards at 20 min interval up to 1 hour and then at 2nd hour and then after every 6 hours for 24 hours.

Official Title
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Comparison of Doses of Nebulized Magnesium Sulphate as an Adjuvant Treatment With Salbutamol in Children With Status Asthmaticus

Conditions
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Status Asthmaticus

Intervention / Treatment
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* Drug: Magnesium Sulfate 500 mg/ml+ ventolin
* Drug: Ventolin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 2 to 12 years of age. Children with the diagnosis of asthma having a pram score of more than 4. Children with reactive airways Exclusion Criteria: Critically ill children who require intubation or mechanical ventilation. Having hypersensitivity or allergy to MgSO4. with history of chronic lung impairment. Whose parents are not giving informed consent for participation in research.

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: Parallel Assignment
Interventional Model Description: Eligible patients were divided in two groups. In group A, patients received 3 back-to-back nebulization with Ventolin solution only using nebulizer machine and face mask after every 20 minutes for 60 minutes. In group B, patients were divided into 3 subgroups and each subgroup received both Ventolin and MgSO4 with three different doses after every 20 minutes for 60 minutes
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nebulized Ventolin<br>Nebulized Ventolin will given to 1st group after every 20 min for 1 hour | Drug: Ventolin<br>* it will be given to control group in nebulized form after every 20 min in 1st hour<br>* Other names: Salbutamol;|
| Experimental: Nebulized Magnesium Sulphate + Ventolin<br>Dose of Nebulized Magnesium sulphate will vary in 3 subgroups. | Drug: Magnesium Sulfate 500 mg/ml+ ventolin<br>* 3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form<br>* Other names: MgSO4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline | The outcome measure was the response to treatment in terms of change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline, i.e; suprasternal indrawing, scalene retractions, wheezing, air entry, oxygen saturation on room air. Change in PRAM score means decrease in score i.e; mild (0-4), moderate (5-8), severe(9-12), impending respiratory failure (12+). | 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment | 
| Change from baseline Suprasternal indrawing | Absent (0) , Present (2) | 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment | 
| Change from baseline Scalene retractions | Absent (0) , Present (2) | 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment | 
| Change from baseline Wheezing | Absent (0), Expiratory only (1), Inspiratory and expiratory (2) Audible without (3) stethoscope/silent chest with minimal air entry | 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment | 
| Change from baseline Air entry | Normal (0), Decreased at bases (1), Widespread decrease (2), Absent/minimal (3) | 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment | 
| Change from baseline Oxygen saturation on room air | >93% (0), 90%-93% (1) or <90% (2) | 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | curtailment in the length of hospital stay | 24 hours | 
| Hospital stay | curtailment in the length of hospital stay | 48 hours | 

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