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.

Bronchial Asthma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02455687
• Other study ID #: 1400046
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Hamad Medical Corporation
• Contact: Khalid Alansari, MD
• Phone: +974-55336166
• Email: kalansari[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• Emergencies

Intervention

Drug:
• Hi-dose iv MgSO4

• Nebulized budesonide

• Std-dose iv MgSO4

• Nebulized normal saline

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to medical readiness for discharge.	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	Overall length of the hospital stay (hours/days) .	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
Secondary	The rate of admission to pediatric intensive care unit (%)	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
Secondary	Comparison of clinical response in severity score (%)	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
Secondary	Frequency of need for revisit and readmission to pediatric emergency center for same diagnosis(%)	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