No benefit of nebulized magnesium with albuterol in reractory pediatric asthma: JAMA
A recent study in children with refractory acute asthma showed nebulized magnesium with albuterol, compared with placebo with albuterol, did not significantly decrease the hospitalization rate for asthma within 24 hours.
The trial details have been published in the JAMA Network on November 24, 2020.
Previously published pediatric asthma studies of nebulized magnesium were small, and had methodological limitations such as lack of focus on health care utilization outcomes and not limiting participants to those not responsive to initial optimized care. But, the Magnesium Nebulization Utilization Management in Pediatric Asthma (MAGNUM PA) Trial was designed to evaluate the effectiveness of inhaled magnesium in children who presented in the Emergency Department with an acute asthma exacerbation and remained in moderate or severe respiratory distress after evidence-based standardized initial therapy.
Researchers designed a randomized, double-blind, parallel-group, placebo-controlled trial comparing the effect of nebulized magnesium sulfate with albuterol vs placebo with albuterol. The trial duration was between September 26, 2011, and November 19, 2019, in 7 tertiary-care pediatric emergency departments in Canada. Among 5846 screened children, 4332 were excluded, 273 declined participation, 423 otherwise excluded, 818 were randomized, and 816 children with refractory acute asthma were analyzed.
The participants were randomly assigned to nebulized albuterol treatments with either magnesium sulfate (n = 410) or 5.5% saline placebo (n = 408) received 3 consecutive nebulization treatments, consisting of 5 mg (1 mL) of albuterol and either 600 mg (1.2 mL) of magnesium sulfate (Sandoz) or 1.2 mL of 5.5% saline. Sterile water (3.8 mL) was added to each nebulization treatment in both groups to achieve identical tonicity of both intervention and placebo solutions. Researchers set the primary outcome as physicians' decision to hospitalize children for persistent respiratory distress or the need for supplemental oxygen within 24 hours of randomization. Pediatric Respiratory Assessment Measure (PRAM) score; respiratory rate; oxygen saturation at 60, 120, 180, and 240 minutes; changes in blood pressure at 20, 40, 60, 120, 180, and 240 minutes; and albuterol treatments within 240 minutes were considered as secondary outcomes. Adverse drug reactions were monitored and codified using MedDRA.
KEY FINDINGS OF THE STUDY WERE:
The hospitalization rate in magnesium group was 43.5% and for placebo group it was 47.7% suggesting no statistically significant treatment effect of magnesium and albuterol vs placebo
There were no significant differences between the groups in the changes from baseline to 240 minutes in PRAM score (difference in changes are 0.14 points)
The difference in change for respiratory rate was 0.31 breaths/min; For oxygen saturation, it was −0.05% and for systolic blood pressure, it was 0.61 mm Hg suggesting no significant difference between the 2 groups.
The Mean number of additional albuterol treatments for the magnesium group was 1.49 and for the placebo group it was 1.59
Nausea/vomiting or sore throat/nose occurred in 17 of the 409 children who received magnesium (4%) and 5 of the 407 who received placebo (1%).
The authors concluded, "Among children with refractory acute asthma in the ED, nebulized magnesium with albuterol, compared with placebo with albuterol, did not significantly decrease the hospitalization rate for asthma within 24 hours."
"The findings do not support the use of nebulized magnesium with albuterol among children with refractory acute asthma" the authors further added.
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JAMA. 2020;324(20):2038-2047. doi:10.1001/jama.2020.19839