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.

  • STATUS
    Recruiting
  • End date
    Oct 19, 2023
  • participants needed
    240
  • sponsor
    Hamad Medical Corporation
Updated on 4 October 2022
budesonide
inhaled steroids
asthma attack

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.

Details
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

Eligibility

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
Immunodeficiency
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note