Salbutamol Safety in Children Under 2 Years of Age With Acute Wheezing: A Meta-analysis of Randomized Controlled Trials

To perform a meta-analysis of randomized controlled trials to determine the safety of short-term inhaled salbutamol (albuterol) use in children younger than 2 years with acute wheeze.The study reviewed 7 studies, which included 597 patients younger than 2 years who inhaled salbutamol for either bronchiolitis or wheezing. Inclusion criteria included an age younger than 2 years, treatment for wheezing or bronchiolitis, and reporting of adverse drug reactions.The authors conducted a meta-analysis of randomized controlled trials to evaluate adverse drug reactions (ADRs) associated with salbutamol use for wheezing and bronchiolitis in infants younger than 2 years. A systematic literature search was performed across PubMed, Trip, MEDLINE, and the Cochrane Library. Three reviewers assessed studies for ADR documentation, and RevMan V.5.4 was used for analysis. Study quality was evaluated using the Cochrane risk-of-bias tool.Out of 3521 references, 7 studies met the inclusion criteria, totaling 597 infants (273 received salbutamol and 324 were controls). No significant difference in ADR incidence was found between groups (19% vs 13.3%; odds ratio [OR], 2.12; 95% CI, 0.69–6.51; P = .19). Excluding hypertonic saline groups, results remained nonsignificant (21.9% vs 17.4%; OR, 1.50; 95% CI, 0.80–2.81; P = .20). However, in a subset excluding MDI use (nebulized salbutamol only), ADRs were significantly higher (6.4% vs 1.2%; OR, 6.76; 95% CI, 2.01–22.71; P = .002), with 1 study reporting severe tremors that led to discontinuation.No significant difference in ADRs was found between salbutamol and control groups in infants younger than 2 years. However, nebulized salbutamol was associated with more ADRs than MDI, including tremulousness in 1 case.The safety and effectiveness of albuterol sulfate inhalation solution (salbutamol) in children younger than 2 years have not been established, nor has it been approved by the Food and Drug Administration in the United States. Research demonstrates that albuterol has no effect on improving outcomes or reducing hospital stays in children with bronchiolitis who are younger than 2 years. However, in other young children with acute asthma or wheezing, albuterol can be helpful. This article provides reassuring evidence that inhaled albuterol can be safely used in children younger than 2 years, with the administration via a metered-dose inhaler being potentially safer than a nebulized formulation. A larger-scale randomized controlled trial would help obtain additional data on the safety of albuterol in infants.