Clinical trial NCT02455687: 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.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bronchial Asthma
Keywords: Bronchial Asthma
Intravenous magnesium sulfate
Inhaled budesonide
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to medical readiness for discharge.
timeFrame: 3 years
Secondary outcomes:
measure: Overall length of the hospital stay (hours/days) .
timeFrame: 3 years
measure: The rate of admission to pediatric intensive care unit (%)
timeFrame: 3 years
measure: Comparison of clinical response in severity score (%)
timeFrame: 3 years
measure: Frequency of need for revisit and readmission to pediatric emergency center for same diagnosis(%)
timeFrame: 3 years
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Sidra Medicine
name: Khalid Alansari, MD
role: STUDY_DIRECTOR
References: