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Completed

NCT Number: NCT04497766

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

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.

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Key information

Conditions

Asthma in Children

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King edward medical university/mayo hospital lahore

Lahore, Punjab Province, 56000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebulized Magnesium sulfate

Drug

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

Other names: Nebulized MgSO4

Intravenous magnesium sulphate

Drug

pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour

Other names: IV MgSO4

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.

    Time frame: 6 hours

    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 outcomes

  1. duration of ICU stay

    Time frame: 72 hours/3 days

    this will be measured in hours

  2. duration of hospital stay

    Time frame: 120 hours/5 days

    this will be measured in hours

Sponsors and collaborators

Lead sponsor

Saima Khatoon

Other

Collaborators

  • King Edward Medical University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2020
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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