Magnesium in acute pediatric asthma in the emergency department (MAGICIAN)—A multicentre randomized controlled clinical trial protocol
Abstract
Background: While guidelines recommend intravenous magnesium (IVMg) for refractory pediatric acute asthma, evidence for benefit is scant and disparate. IVMg therapy is resource-intensive and can cause hypotension. To determine if IVMg alters the exacerbation course, it must be given early, and the clinical effect measured at the peak effect of routine co-interventions.
Primary aim: In children with acute asthma remaining in moderate-severe respiratory distress after initial ED therapy, to determine if early IVMg therapy is associated with a significantly greater improvement in respiratory distress at 2 hours after starting IVMg, compared to placebo.
Hypothesis: IVMg will yield significantly greater Pediatric Respiratory Assessment Measure (PRAM) improvement of ≥1.0 point than placebo.
Study design: A randomized double-blind placebo-controlled trial in 6 Canadian pediatric EDs of otherwise healthy children 2-17 years old with acute asthma and PRAM ≥5 after initial 1 hour therapy with systemic corticosteroids and 3 inhaled salbutamol ± ipratropium treatments.
Intervention: IVMg sulfate (75 mg/kg, max 2.5 g) or normal saline placebo over 30 minutes.
Primary outcome: PRAM 2 hours post-intervention start. Secondary: PRAM ≤3 at 2 hours; change in PRAM and vital signs over 3 hours; hospitalization; asthma re-visits by 72 hours.
Sample size: With 192 patients, a two-sided test and alpha 0.05 have 80% power to achieve statistical significance if IVMg yields a difference in PRAM…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 192 participants or records.
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