Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation
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ClinicalTrials.gov Identifier: NCT01515995 |
Recruitment Status :
Completed
First Posted : January 24, 2012
Results First Posted : February 21, 2019
Last Update Posted : February 21, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Nebulized magnesium sulfate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Nebulized Magnesium Sulfate Versus Normal Saline as a Vehicle for Albuterol in Children With Moderate to Severe Asthma Exacerbation: a Randomized Controlled Trial |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | October 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Magnesium sulfate group
15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
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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 Name: 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 Name: Inhaled magnesium sulfate |
- 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.

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Ages Eligible for Study: | 7 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515995
United States, Texas | |
Children's Medical Center Dallas | |
Dallas, Texas, United States, 75390 |
Study Director: | Mohamed Badawy, MD | UT Southwestern Medical Center |
Responsible Party: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT01515995 |
Other Study ID Numbers: |
( STU 072011-043) |
First Posted: | January 24, 2012 Key Record Dates |
Results First Posted: | February 21, 2019 |
Last Update Posted: | February 21, 2019 |
Last Verified: | January 2019 |
Magnesium sulfate Childhood asthma Emergency department |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Magnesium Sulfate Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents |