Nebulized budesonide vs. ipratropium as an add-on to salbutamol in preschool wheeze ‒ a randomized controlled trial

Introduction and aim. Acute wheeze is common cause of emergency visits and hospitalization in preschool children. This randomized controlled trial directly compared nebulized budesonide versus ipratropium bromide as add-on therapy to salbutamol in children aged 1–5 years with moderate-to-severe acute wheeze. Material and methods. This hospital-based randomized controlled trial included 84 children equally assigned to two groups. Group A received nebulized budesonide with salbutamol, and Group B received nebulized ipratropium bromide with salbutamol. The co-primary outcomes were the change in Pediatric Respiratory Assessment Measure (PRAM) score from baseline to 60 minutes and the PRAM score trajectory during the first 60 minutes. Results. Baseline PRAM scores were comparable between groups. Group A showed significantly lower PRAM scores at 20, 40, 60 minutes, with greater mean PRAM reduction at 60 minutes (p<0.05). Mean time to achieve PRAM≤4 was shorter in Group A. Group A children had a significantly shorter hospital stay. Conclusion: Nebulized budesonide as an add-on to salbutamol was associated with greater short-term improvement in PRAM scores and shorter hospital stay than ipratropium bromide; larger multicenter studies are needed.