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Completed

NCT Number: NCT01515995

Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation

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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Medical Center Dallas

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age ≥ seven years
  • Previous diagnosis of asthma or previous episode of wheezing treated with beta-agonist medication
  • Able to complete bedside spirometry
  • FEV1 < 70% predicted

Exclusion criteria

  • Known allergy to magnesium sulfate
  • Known contra-indication to albuterol
  • Respiratory distress occurring as a result of bedside spirometry
  • History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
  • Pregnancy
  • Use of oral steroid medication within 72 hours of presentation
  • Radiographic evidence of pneumonia at presentation
  • Intubation during the current encounter prior to study enrollment
  • Administration of intravenous magnesium sulfate prior to study enrollment
  • Prior participation in this study

Treatment and study plan

Nebulized Magnesium sulfate

Drug

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 names: Inhaled magnesium sulfate

Primary outcomes

  1. Change in Forced Expiratory Volume in One Second (FEV1) %

    Time frame: Baseline and one hour after treatment

    Change in forced expiratory volume in one second (FEV1) as measured by bedside spirometry before and after study intervention.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Nebulized Magnesium Sulfate Versus Normal Saline as a Vehicle for Albuterol in Children With Moderate to Severe Asthma Exacerbation: a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 24, 2012
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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