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Salbutamol safety in children under 2 years of age with acute wheezing: a meta-analysis of randomised controlled trials
  1. Luca Pierantoni1,
  2. Edoardo Muratore2,
  3. Sara Cerasi2,
  4. Daniele Zama1,3,
  5. Chiara Del Bono4,
  6. Davide Gori5,
  7. Riccardo Masetti2,3,
  8. Marcello Lanari1,3
  1. 1Paediatric Emergency Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola, Bologna, Emilia-Romagna, Italy
  2. 2Paediatric Hematology and Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola, Bologna, Emilia-Romagna, Italy
  3. 3Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy
  4. 4Specialty School of Paediatrics, Alma Mater Studiorum, University of Bologna, Bologna, Italy
  5. 5Department of Biomedical and Neuromotor Sciences (DIBINEM), Università di Bologna, Bologna, Emilia-Romagna, Italy
  1. Correspondence to Dr Daniele Zama; daniele.zama2{at}unibo.it; Dr Chiara Del Bono; chiara.delbono{at}studio.unibo.it

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 outcome(s) and measure(s) 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.

  • Child Health
  • Paediatric Emergency Medicine
  • Pharmacology

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/archdischild-2023-326556

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • LP and EM are joint first authors.

    • LP and EM contributed equally.

    • Correction notice This paper has been corrected since it was first published. Some author names were inverted.

    • Contributors ME, CDB, CS and LP had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: LP and ML. Acquisition, analysis or interpretation of data: ME, CS, CDB and LP. Drafting of the manuscript: ME, CS and CDB. Critical revision of the manuscript for important intellectual content: LP, ZD, ML, RM and GD. Statistical analysis: CS, ME, CDB and GD. Administrative, technical or material support: GD and ZD. Supervision: LP, ZD, RM and ML. Guarantor: LP

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.