Condition: Asthma · Sponsor: Suzanne Schuh
Despite optimal initial emergency department (ED) therapy, 50% of children with severe acute asthma have ongoing moderate-severe respiratory distress. Guidelines recommend intravenous magnesium (IVMg) for them, yet evidence for IVMg efficacy is scant and disparate. While early small Randomized Controlled Trials (RCTs) suggested hospitalization benefit, recent large observational studies found no association between IVMg and improved outcomes. IVMg therapy is resource-intensive, can cause hypotension and demands close monitoring. Previous RCTs only assessed early Mg effect at 1-2 hours, overlooked the peak effect of key co-interventions such as corticosteroids and did not use validated scores. IVMg use is variable and often delayed until ≥4 hours after ED therapy is started and after the hospitalization decision has been made. Thus, in observational studies children given IVMg are 6-10 times more likely to be hospitalized; these studies have major confounding and the true IVMg treatment effect is thus unknown. To conclusively determine if IVMg alters the exacerbation course, it must be given early, and the primary outcome measure should be the severity of respiratory distress measured at the peak effect of key co-interventions to focus on a clinically meaningful and objective effect. The Pediatric Respiratory Assessment Measure (PRAM)-a valid, discriminative, reproducible and responsive-to-change instrument-is thus the ideal primary outcome measure. Hospitalization outcome has…
This description comes directly from the study's public registry record.
Sunita O'Shea · 416-813-7654 · sunita.oshea@sickkids.ca
Yaron Finkelstein, MD · 416-813-7654 · yaron.finkelstein@sickkids.ca
Always discuss trial participation with your own doctor first.
| 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 |
| The Hospital for Sick Children | Toronto, Ontario, Canada | Recruiting |
| CHU-Sainte Justine Hospital | Montreal, Quebec, Canada | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06785272