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. CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2018/06/014400.