Nebulized Magnesium Sulfate

Condition(s) targeted: Asthma

Intervention: Nebulized Magnesium Sulfate (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Children's Hospital Medical Center, Cincinnati

Official(s) and/or principal investigator(s):
Laurie Johnson, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati

Overall contact:
Kansie E. Drummond, MA, Phone: 513-636-3526, Email: Kansie.Drummond@cchmc.org

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.

Official title: Nebulized Magnesium Sulfate Compared to Saline in Addition to Albuterol and Ipratropium Treatments in Moderate to Severe Pediatric Asthmatic Patients: A Randomized Controlled Clinical Trial

Study design: Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Minimum age: 7 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Kansie E. Drummond, MA, Phone: 513-636-3526, Email: Kansie.Drummond@cchmc.org

Starting date: September 2007
Last updated: August 28, 2007