Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

April 3, 2023 updated by: Dr.Rabia Asif, Ziauddin University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 1

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
    • Sindh
      • Karachi, Sindh, Pakistan, 75530
        • Rabia Asif

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:

  1. Children between 2 to 12 years of age.
  2. Children with the diagnosis of asthma having a pram score of more than 4.
  3. Children with reactive airways

Exclusion Criteria:

  1. Critically ill children who require intubation or mechanical ventilation.
  2. Having hypersensitivity or allergy to MgSO4.
  3. with history of chronic lung impairment.
  4. Whose parents are not giving informed consent for participation in research.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline
Time Frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
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
Time Frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Absent (0) , Present (2)
20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Scalene retractions
Time Frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Absent (0) , Present (2)
20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Wheezing
Time Frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
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
Time Frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
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
Time Frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
>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
Time Frame: 24 hours
curtailment in the length of hospital stay
24 hours
Hospital stay
Time Frame: 48 hours
curtailment in the length of hospital stay
48 hours

Collaborators and Investigators

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

Sponsor

Ziauddin University

Investigators

  • Principal Investigator: Rabia Asif, MBBS, PGT, Ziauddin Hospital

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)

January 1, 2022

Primary Completion (Actual)

November 12, 2022

Study Completion (Actual)

November 12, 2022

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doses of Nebulized MgSO4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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