Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as
      a vehicle for albuterol in children with moderate to severe asthma exacerbation.
    

Detailed description: 
      Patients presenting to the Emergency Department for acute asthma exacerbation will receive
      standard care of up to three doses of albuterol and ipratropium bromide plus oral steroid
      medication. Those seven years of age and older who require further treatment will be screened
      for eligibility. Eligibility screening will comprise measurement of forced expiratory volume
      in one second (FEV1) with a bedside spirometer by a respiratory therapist. Children under the
      age of seven are generally unable to complete spirometry maneuvers and will thus be excluded.
      The Pediatric Asthma Severity Score (PASS) will also be noted by a respiratory therapist.
      Patients able to complete spirometry testing and with an FEV1 less than 70% of predicted (the
      definition of moderate asthma exacerbation) will be enrolled. Enrolled patients will be
      randomized to receive either Children's Medical Center standard care of 15 mg albuterol
      diluted in 22 ml of normal saline or the study intervention of 15 mg of albuterol diluted in
      22 ml of magnesium sulfate solution. This solution will be prepared at the time of use by a
      pharmacist in the Emergency Department and will consist of 22 ml of a commercially available
      40 mg/ml magnesium sulfate solution (880 mg). The nebulizer treatment will be given over
      approximately one hour via a large volume nebulizer at 25 ml/hr. Physicians, nurses, and
      respiratory therapists will be blinded to the diluent used. Vital signs will be noted at
      baseline. Heart rate, heart rhythm, respiratory rate, and pulse oximetry will be monitored
      continuously while blood pressure will be measured at baseline and every 15 minutes during
      study medication administration. The study physician, treating physician, and/or bedside
      nurse will monitor these values for any clinically significant changes. At the end of the 15
      mg albuterol treatment FEV1 and PASS will again be noted. Any further treatments needed, as
      determined by the treating physician, will be given following Children's Medical Center
      standard of care. At the discretion of the treating physician intravenous magnesium sulfate
      may be used post study intervention. The dose used for study participants will be the
      Children's Medical Center standard dose of 75 mg/kg (max 3 g) minus 880 mg to avoid the risk
      of magnesium sulfate overdose. Further treatments and patient disposition will be observed by
      study personnel and noted. Bounce-back rates will be collected by review of enrolled
      patients' medical record.
    

Intervention name(s): Nebulized magnesium sulfate
Intervention type(s): Drug
Intervention description(s): 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
Versus
15 mg albuterol in 22 ml of normal saline via nebulizer over one hour
Other intervention name(s): Inhaled magnesium sulfate
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Magnesium sulfate; Childhood asthma; Emergency department