In children with refractory acute asthma who present to the emergency department (ED), the use of nebulized magnesium with albuterol, compared with placebo, does not significantly decrease the hospitalization rate for asthma in the first 24 hours. Researchers conducted a randomized, double-blind, parallel-group clinical trial (ClinicalTrials.gov Identifier: NCT01429415) between September 26, 2011, and November 19, 2019, in 7 tertiary care pediatric EDs in Canada. Results of the analysis were published in JAMA.
The investigators sought to assess the effectiveness of using nebulized magnesium in pediatric patients with acute asthma who remain in moderate or severe respiratory distress following initial treatment. The primary study outcome was hospitalization for asthma within 24 hours of ED presentation. Secondary outcomes included Pediatric Respiratory Assessment Measure (PRAM) score; respiratory rate, oxygen saturation at 60, 120, 180, and 240 minutes; albuterol treatments within 240 minutes; and blood pressure (BP) at 20, 40, 60, 120, 180, and 240 minutes.
All participants were otherwise healthy children between 2 and 17 years of age with moderate to severe asthma, as defined by a PRAM score of 5 or more on a 12-point scale following a 1-hour treatment with an oral corticosteroid, along with 3 inhaled albuterol and ipratropium treatments. The participants were randomly assigned to 3 nebulized albuterol treatments with either magnesium sulfate (n=410) or 5.5% saline placebo (n=408). Of these 818 individuals, 816 completed the trial: 409 in the magnesium arm and 407 in the placebo arm. The median participant age was 5 years, and 63% were males.
Results of the study showed that 43.5% (178 of 409) of the magnesium-treated children were hospitalized, compared with 47.7% (194 of 407) of the placebo-treated patients (difference, -4.2%; absolute risk difference 95% [exact] CI, -11% to 2.8%; P =.26). Further, no significant between-group differences in changes from baseline to 240 minutes in PRAM score (difference of changes, 0.14 points; 95% CI, -0.23 to 0.50; P = .46); respiratory rate (unadjusted, 0.17 breaths/min; 95% CI, -1.32 to 1.67; P =.82); oxygen saturation (unadjusted, -0.04%; 95% CI, -0.53% to 0.46%; P =.88); systolic BP (unadjusted, 0.78 mm Hg; 95% CI, -1.48 to 3.03; P =.50); or mean number of additional albuterol treatments (magnesium: 1.49 vs placebo: 1.59; unadjusted risk ratio, 0.94; 95% CI, 0.79-1.11; P =.47) were reported.
With respect to the occurrence of adverse events, nausea/vomiting or sore throat was reported in 4% (17 of 409) of magnesium-treated patients’ vs 1% (5 of 407) of placebo-treated patients. None of the patients in either group experienced more than 1 adverse event.
The investigators concluded that the findings from this study do not support the use of nebulized magnesium along with albuterol in pediatric patients with refractory acute asthma.
Schuh S, Sweeney J, Rumantir M, et al; for the Pediatric Emergency Research Canada (PERC) Network. Effect of nebulized magnesium vs placebo added to albuterol on hospitalization among children with refractory acute asthma treated in the emergency department: a randomized clinical trial. JAMA. 2020;324(20):2038-2047. doi:10.1001/jama.2020.19839