The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00522444
(institution in Canada is conducting a similar clinical trial with potential of validating use.)
Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma exacerbations, though limited work has been done in the pediatric population. Current therapeutic questions include the effect of more than one dose of nebulized magnesium, the possibility of a sustained effect (greater than 20 minutes) after a treatment, the potential benefit in children younger than 5 years of age, and the use of an asthma score to re-assess patients after treatment with this medication. The purpose of this double-blind randomized placebo-controlled clinical trial is the evaluate the effect of multiple doses of nebulized magnesium sulfate versus saline in addition to standard asthma therapy on clinical asthma score and FEV1 in children 7 to 18 years of age with a moderate to severe acute asthma exacerbation. Our hypothesis is that nebulized magnesium sulfate, when added to traditional bronchodilator therapy, will improve acute asthma exacerbations more rapidly than standard therapy alone. The primary outcomes are asthma score and FEV1 values obtained after two nebulized magnesium sulfate compared to placebo treatments. This therapy will be supplemental to standard therapy of albuterol and ipratropium nebulized treatments and systemic corticosteroids. The secondary outcome is patient disposition (discharge home or hospitalization). Patients with known asthma will be approached for enrollment and informed consent obtained if the asthma score after the first albuterol treatment is "2" or greater. One hundred-seventy patients will be enrolled and randomized to either the treatment group or the placebo group. The change from baseline in asthma scores and FEV1 values will be compared among the control and treatment groups to assess for any benefit of the addition of nebulized magnesium sulfate to the treatment regimen.
Condition or disease
Drug: Nebulized Magnesium Sulfate
Children's Hospital Medical Center, Cincinnati has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
7 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Pediatric Patients ages 7-18 years old
Parental report of previous history of asthma or wheezing episode documented by physician at least 3 months prior to enrollment
Acute Asthma exacerbation as defined by attending physician and asthma score (PASS) of greater than or equal to 2 after initial albuterol treatment
Temperature in triage of greater than or equal to 39 degrees Celsius
Systemic corticosteroids in past 72 hours
Medical history significant for cardiac, renal, or malignant disease, or bronchopulmonary dysplasia or cystic fibrosis
Patients whose care is initiated in the trauma bay due to need for rapid stabilization or any patient deemed too ill to participate by the attending ED physician
Altered Mental Status (Glasgow Coma Score of < 15)
Asthma Score (PASS) of > 6, and in conjunction with FEV1 < 45% predicted
Oxygen saturation < 90% while on 6L of 100% oxygen via face mask
Respiratory distress occurring after FEV1 attempt in conjunction with any increase in asthma score (PASS) from previous score
Enrollment in any other research study in the previous 30 days
Previous enrollment in this RCT
Initial administration of continuously nebulized albuterol or dose of IV Magnesium Sulfate in the ED
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Reproductive Control Agents