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NCT Number: NCT04929626

Different Doses of Nebulized Magnesium Sulphate in 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.

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Key information

Conditions

Status Asthmaticus Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rabia Asif

Karachi, Sindh, 75530, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Magnesium Sulfate 500 mg/ml+ ventolin

Drug

3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form

Other names: MgSO4

Ventolin

Drug

it will be given to control group in nebulized form after every 20 min in 1st hour

Other names: Salbutamol

Primary outcomes

  1. 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+).

  2. Change from baseline Suprasternal indrawing

    Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment

    Absent (0) , Present (2)

  3. Change from baseline Scalene retractions

    Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment

    Absent (0) , Present (2)

  4. 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

  5. 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)

  6. 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)

Secondary outcomes

  1. Hospital stay

    Time frame: 24 hours

    curtailment in the length of hospital stay

  2. Hospital stay

    Time frame: 48 hours

    curtailment in the length of hospital stay

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2021
Registry last updated
Apr 5, 2023

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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