A clinical trial to study the effect of Magnesium Sulphate for treatment of acute asthma in children by nebulisation.

Phase 2

Completed

• Conditions: Health Condition 1: null- ASTHMA IN CHILDRENHealth Condition 2: J455- Severe persistent asthma

• Registration Number: CTRI/2018/03/012517
• Lead Sponsor: Dr SRADHANANDA ROUT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-10-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Age group 1-14years

2.Clinician diagnosed asthma

3.Moderate to Severe Acute Asthma Attack defined as PRAM Score >_ 5

Exclusion Criteria

1.Patients who had life-threatening features [silent chest, cyanosis, bradycardia, arrhythmia, hypotension, coma,requiring intubation]

2. Any contraindication to either nebulised or intravenous Magnesium Sulphate [hepatic or renal failure, heart block, or known hypomagnesemia]

 

3. Medications containing Magnesium preparations in last 48 hours before recruitment.

4.Patients with alternative diagnosis [ Pneumonia ,pleural effusion etc.]

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Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of Hospital Stay <br/ ><br>And improvement in PRAM ScoreTimepoint: 2 years <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Need for oral and parenteral steroid <br/ ><br>2.Duration of oxygen therapy <br/ ><br>3.Trends in PEFR and FEV1 <br/ ><br>4. Need for ICU/ Intubation <br/ ><br>5. Adverse effects if any ascribed to nebulised magnesium sulphate.Timepoint: 2 years