Magnesium Nebulization Utilization in Management of Pediatric Asthma

Summary

Acute asthma is the most common cause of pediatric hospitalizations. While the investigators know that repeat inhalations of ß2 agonists and ipratropium with early oral steroids substantially reduce hospitalizations, many children are resistant to this standard initial therapy. About a third of children remaining in moderate to severe distress after standard therapy are admitted to hospital and comprise 84% of pediatric acute asthma hospitalizations. Finding safe, non-invasive, and effective strategies to treat children resistant to standard therapy would substantially decrease hospitalizations resulting in considerable health care savings and reduction of the psycho-social burden of the disease. While studies of magnesium sulfate (Mg) given intravenously (IV) suggest that this agent can reduce hospitalizations in both adults and children resistant to standard initial therapy Nebulization is an alternate route for administering Mg. This route has the advantage of being non-invasive and is likely much safer due to lower systemic delivery. Direct delivery via nebulization allows higher Mg concentrations at the target site, the lower airways, with a smaller total drug dose. The investigators propose to conduct a properly designed study to clarify the role of nebulized Mg.

Conditions

• Acute Asthma

Interventions

DRUG

Magnesium Sulfate Sandoz

Each treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz

DRUG

Sodium Chloride , USP PPC

Intervention: The control group will receive Sodium Chloride , USP PPC (1.2 mL hypertonic 5.5% saline with 5 mg Salbutamol - GlaxoSmithKline/Pharmascience

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Alberta Children's Hospital

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• Children's Hospital of Eastern Ontario

  collaborator OTHER

• Stollery Children's Hospital

  collaborator OTHER

• The Children's Hospital of Winnipeg

  collaborator OTHER

• Provincial Health Services Authority

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Suzanne Schuh, MD · The Hospital for Sick Children

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-26

Primary Completion

2019-11-19

Completion

2019-11-22

Countries

• Canada

Study Locations