IV magnesium for children with severe asthma attacks in the emergency department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled trial across six centres comparing IV magnesium sulfate (75 mg/kg, max 2.0 g) to an identical-volume 0.9% saline placebo given as a 30-minute infusion. Eligible children receive the infusion after routine systemic corticosteroids and three inhaled bronchodilator treatments if their PRAM score remains ≥5. Outcomes are recorded during a 180-minute ED observation period and again at 72 hours after ED discharge, with monitoring for hypotension and other adverse effects. The trial aims to address prior inconsistent evidence by using validated clinical scores and standardized timing of the intervention relative to co-therapies.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Age 2.00-17.99 years (prior to 18th birthday),
2. Diagnosis of asthma, defined as an asthma or probable asthma diagnosis/asthma-like phenotype made by a physician (this includes ED physician) in a patient who in the opinion of the treating ED physician requires therapy for acute asthma in the ED (GINA asthma guidelines, 2024).
3. Moderate-severe asthma after initial therapy with 3 treatments of inhaled salbutamol and ipratropium, defined as an eligibility PRAM ≥5, indicating a strong association with hospitalization.

Exclusion criteria:

1. Receipt of IVMg within 24 hours prior to ED arrival.
2. Need for airway support on arrival. (Airway support on arrival meeting exclusion criteria will include immediate need for high flow nasal cannula therapy, non-invasive CPAP/bi-PAP ventilation or invasive ventilation with endotracheal intubation, as decided by the attending Emergency Department (ED) physician. Supplemental oxygen therapy will not represent an exclusion criterion.)
3. Known renal, chronic pulmonary, neurologic, cardiac or systemic disease: these may influence outcomes after Mg.
4. Known hypersensitivity to Mg sulfate.
5. Previous enrollment.
6. Poor mastery of English and/or French language precluding informed consent understanding.
7. No phone/email; unavailable for follow-up

Where it's running

• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting
• Alberta Children's Hospital
  Calgary, Alberta, Canada Not yet recruiting
• Stollery Children's Hospital
  Edmonton, Ontario, Canada Not yet recruiting
• McMaster Children's Hospital
  Hamilton, Ontario, Canada Not yet recruiting
• Children's Hospital of Eastern Ontario
  Ottawa, Ontario, Canada Not yet recruiting
• CHU-Sainte Justine Hospital
  Montreal, Quebec, Canada Not yet recruiting

Study contacts

• Principal investigator: Suzanne Schuh, MD — The Hospital for Sick Children
• Study coordinator: Sunita O'Shea
• Email: sunita.oshea@sickkids.ca
• Phone: 416-813-7654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.