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.

  • End date
    Oct 19, 2023
  • participants needed
  • sponsor
    Hamad Medical Corporation
Updated on 4 October 2022
inhaled steroids
asthma attack


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.


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.

Condition Bronchial Asthma
Treatment Normal saline, Intravenous magnesium sulfate, Inhaled budesonide, Hi-dose iv MgSO4, Nebulized budesonide, Std-dose iv MgSO4, Nebulized normal saline
Clinical Study IdentifierNCT02455687
SponsorHamad Medical Corporation
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Prematurity <34 weeks of gestation
Critically ill children requiring immediate intubation or ICU admission
Transfers from other institutions
Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate
History of neuromuscular disease, cardiac disease, renal disease, liver disease
Underlying chronic lung disease
Radiographic evidence of pneumonia or lung collapse
Hemodynamic instability
Instrumented airway or Tracheotomy
Colostomy or ileostomy
Malabsorption disorder
Known vitamin D deficiency
Receiving Milk of Magnesium for Constipation
Chronic diarrhea (duration for 2 weeks)
Diuretics use
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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