Nebulized Magnesium Sulphate in Bronchiolitis: A Randomized Controlled Trial

Abstract

Objective To evaluate the efficacy and safety of nebulized magnesium sulphate as a bronchodilator in young children aged 1-24 mo with moderate to severe bronchiolitis in comparison to standard therapy. Methods This was an open labeled randomized controlled trial comprising 60 children with moderate to severe bronchiolitis which was randomly assigned to 2 groups. Intervention group received nebulization with 3 mL of 3.2% magnesium sulphate (MgSO 4 ) (iso-osmolar) every 4 hourly for 24 h in addition to standard care and the control group received standard care alone. The primary outcome measure was to compare the improvement of bronchiolitis severity score (BSS) and length of hospitalization. The secondary outcome was to measure the need for noninvasive ventilation, need for admission to intensive care unit (ICU) in the initial visit, to evaluate the safety of magnesium sulphate and need for clinic revisit, hospital readmission and ICU readmission within 2 wk after discharge in both the groups. Results The mean age of children allocated in the control group was 7.4 ± 5.1 mo and 7.7 ± 4.5 mo in the intervention group. There was no significant difference with respect to improvement of BSS or reduced length of hospitalization in both the groups (p > 0.05). BSS monitored sequentially after enrollment at 1, 2, 4, 8, 12, 16, and 24 h did not show statistically significant differences between the groups. Mean length of hospital stay was 2.89 ± 2.25 d in treatment group and 2.96 ± 1.86 d in control group (p = 0.902). No adverse events were observed in both the groups. Conclusion Nebulized magnesium sulphate is not superior to standard therapy in children with moderate to severe bronchiolitis.

Inhaled Magnesium in Acute Bronchiolitis: Another One Bites the Dust?

“…This issue of the Journal reports a randomized controlled trial (RCT) comparing inhaled magnesium sulphate versus standard treatment alone, in bronchiolitis [3]. The trial included 60 infants 1-24 mo old, hospitalized with a clinical diagnosis of moderate-to-severe bronchiolitis.…”

“…The trial [3] was appropriately registered [4], with minor (beneficial) deviations from the stated plan (i.e., reporting of three unplanned outcomes viz. duration of hospitalization, need for noninvasive ventilation, and duration of oxygen therapy).…”

“…The investigators [3] did not use saline as a placebo in the comparison arm. In a sense, this is fortuitous because recently, there has been debate whether saline itself has clinical effects in bronchiolitis [5].…”

“…Of course, it is an entirely different matter that none of the clinical scores are themselves very robust [6]. As in routine practice in most Indian institutions, the investigators [3] did not undertake virology studies to look for RSV.…”

“…An unpublished Indian trial comparing inhaled magnesium vs. hypertonic saline showed comparable results. Although this trial is not comparable to the others [3,7,8] because magnesium was not compared to placebo/no treatment, it is the largest of these trials (220 infants), and it provides valuable information on baseline characteristics and outcomes in the infants.…”