Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation

January 29, 2019 updated by: University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Children's Medical Center Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium sulfate group
15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
Drug: Nebulized magnesium sulfate

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
Active Comparator: Normal Saline group
15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour
Drug: Nebulized magnesium sulfate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and one hour after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Study Director: Mohamed Badawy, MD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ( STU 072011-043)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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