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.

Hamad Medical Corporation (HMC)

Status and phase: Enrolling; Phase 3

Conditions: Bronchial Asthma

Treatments: Drug: Hi-dose iv MgSO4; Drug: Nebulized budesonide; Drug: Nebulized normal saline; Drug: Std-dose iv MgSO4

Study type: Interventional

Funder types: Industry

Identifiers

NCT02455687

1400046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups, including a placebo group

Hi-Mg + Bud

Active Comparator group

Description:

Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide.

Treatment:

Drug: Nebulized budesonide

Drug: Hi-dose iv MgSO4

Hi-Mg + P

Placebo Comparator group

Description:

Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline.

Treatment:

Drug: Nebulized normal saline

Drug: Hi-dose iv MgSO4

Std-Mg + Bud

Active Comparator group

Description:

Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide.

Treatment:

Drug: Std-dose iv MgSO4

Drug: Nebulized budesonide

St-Mg + P

Placebo Comparator group

Description:

Group four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline

Treatment:

Drug: Std-dose iv MgSO4

Drug: Nebulized normal saline