Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.

March 21, 2024 updated by: Hamad Medical Corporation

Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose With/Without Nebulized Budesonide for the Emergency Management of the Severe Asthma. A Randomized Controlled Trial.

Many studies have investigated the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids in addition to the standard treatment for patients with severe asthma attacks.

In this 2x2 factorial design blinded randomized study, no interaction of hypothesized treatments is expected.Investigators hypothesize that two doses of intravenous magnesium sulfate,a high dose followed by a (lower) standard dose, will shorten the time to medical readiness for discharge compared to a single standard dose followed by placebo.The second hypothesis is that nebulized inhaled budesonide will be superior to placebo.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patient with a severe asthma attack will be admitted to the observation area in the Pediatric Emergency Center and assessed for eligibility for the study by the attending physician, based upon our study inclusion/exclusion criteria.

Eligible patients will be enrolled after obtaining written consent from the parents. Patients will receive routine treatment for a severe asthma attack, such as inhaled bronchodilators, plus intravenous steroids and supplementary oxygen if needed. Standard blood work and chest X-Ray will be obtained and bronchial asthma severity score will be measured at baseline before starting treatment,and then at 4,8,12,24,36,48 hr and thereafter. The medical team as well as parents and patient will be blinded to the medications delivered. The patient will be randomized into one of the four study groups and adverse effects of the medications in each group will be monitored and documented carefully.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Recruiting
        • Hamad Medical Corporation

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 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Children 2-14 years of age.
  2. Known to have bronchial asthma.
  3. Presenting in severe asthma exacerbation
  4. Asthma severity score 8 or higher according to PRAM asthma severity .

Exclusion Criteria:

  1. Prematurity <34 weeks of gestation.
  2. Critically ill children requiring immediate intubation or ICU admission.
  3. Transfers from other institutions.
  4. Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
  5. History of neuromuscular disease, cardiac disease, renal disease, liver disease.
  6. Underlying chronic lung disease.
  7. Radiographic evidence of pneumonia or lung collapse .
  8. Hemodynamic instability.
  9. Instrumented airway or Tracheotomy.
  10. Colostomy or ileostomy.
  11. Malabsorption disorder.
  12. Known vitamin D deficiency.
  13. Receiving Milk of Magnesium for Constipation
  14. Chronic diarrhea (duration for 2 weeks)
  15. Diuretics use.
  16. Immunodeficiency.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hi-Mg + Bud
Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide.
Drug: Hi-dose iv MgSO4
Drug: Nebulized budesonide
Other Names:
  • Pulmicort
Placebo Comparator: Hi-Mg + P
Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline.
Drug: Hi-dose iv MgSO4
Drug: Nebulized normal saline
Active Comparator: Std-Mg + Bud
Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide.
Drug: Nebulized budesonide
Other Names:
  • Pulmicort
Drug: Std-dose iv MgSO4
Placebo Comparator: St-Mg + P
Group four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline
Drug: Nebulized normal saline
Drug: Std-dose iv MgSO4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to medical readiness for discharge.
Time Frame: 3 years
The aim of the study is to find out if the two doses of intravenous magnesium sulfate 100 mg/kg followed by 50 mg/kg with or without nebulized budesonide would shorten the length of the emergency center's stay in comparison to the 50 mg/kg dose with or without nebulized budesonide in treating severe asthma attack in children, who are admitted to the pediatric emergency center Al-Sadd, in a double blinded randomized controlled trial. .
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall length of the hospital stay (hours/days) .
Time Frame: 3 years
Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide shorten the length of the emergency center's stay in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide?
3 years
The rate of admission to pediatric intensive care unit (%)
Time Frame: 3 years
Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide decrease the PICU admission rate in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide?
3 years
Comparison of clinical response in severity score (%)
Time Frame: 3 years
Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide decrease the asthma severity score at 4, 8,12,24,36,48,60,72 hours in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide?
3 years
Frequency of need for revisit and readmission to pediatric emergency center for same diagnosis(%)
Time Frame: 3 years

Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide decrease revisit to emergency services in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide?

Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide decrease readmission rate in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide? •
3 years

Collaborators and Investigators

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

Sponsor

Hamad Medical Corporation

Investigators

  • Study Director: Khalid Alansari, MD, Sidra Medicine

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)

June 1, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimated)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1400046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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