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

February 19, 2021 updated by: Saima Khatoon

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 56000
        • King edward Medical University/Mayo Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

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.
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.
6 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saima Khatoon

Collaborators

King Edward Medical University

Investigators

  • Principal Investigator: Muhammad-Haroon Hamid, MBBS,FCPS,FRCP, chairman /Head of department of pediatrics unit1 K.E medical university/mayo hospital l

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137/RC/KEMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be shared after publication on a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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