Salbutamol safety in children under 2 years of age with acute wheezing: a meta-analysis of randomised controlled trials

Abstract

Objective: To evaluate the safety of short-term use of inhaled salbutamol in children under 2 years of age with acute wheezing.

Data sources: Electronic databases (PubMed, Trip, MEDLINE) and the Cochrane Library were searched for studies published up to October 2022.

Study selection: The search was restricted to randomised controlled trials published in English regarding the safety of inhaled salbutamol in wheezing children under the age of 2.

Data extraction and synthesis: The literature search strategy yielded 3532 references. The meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Main outcomes and measures: The incidence of adverse reactions associated with inhaled salbutamol administration compared with placebo.

Results: A total of 24 records were included. In 7 studies involving 597 patients, inhaled salbutamol was compared with controls and no statistically significant difference in the incidence of adverse drug reactions was found between the two groups (OR 2.12, 95% CI 0.69 to 6.51; p=0.19). Salbutamol administration via nebulisation was associated with an increased incidence of adverse reactions (OR 6.76, 95% CI 2.01 to 22.71; p=0.002). None of the studies reported severe cardiac side effects that necessitated withdrawal from the study following salbutamol administration. Only one study reported a significant non-cardiac side effect (severe tremulousness) that necessitated withdrawal from therapy.

Conclusions: Inhaled salbutamol can be safely used in children under 2 years of age with acute wheeze with the administration via a metered-dose inhaler being potentially safer than a nebulised formulation. Neither of the formulations was associated with severe adverse effects.

Keywords: Child Health; Paediatric Emergency Medicine; Pharmacology.