Efficacy and safety of vagus nerve stimulation for the treatment of status epilepticus in children: a study protocol for a systematic review and meta-analysis.

Abstract

Status epilepticus, particularly in children, is a neurological emergency with significant morbidity and mortality. When standard anticonvulsant therapies fail, vagus nerve stimulation (VNS) has emerged as a potential acute intervention. However, its efficacy and safety remain uncertain due to a lack of robust evidence. This systematic review aims to synthesise existing data to evaluate the role of VNS in treating paediatric status epilepticus. This protocol follows Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. A comprehensive search of PubMed, Embase, Cochrane Central Register of Controlled Trials and Web of Science will be conducted from inception to 31 October 2025. Studies involving paediatric patients (0-18 years) receiving VNS for status epilepticus in acute care settings will be included. Risk of bias will be assessed using Cochrane Risk of Bias 2 and ROBINS-I tools. If feasible, random-effects meta-analysis will be performed to pool effect estimates for primary outcomes; otherwise, narrative synthesis will be conducted. Heterogeneity will be evaluated using the I² statistic. Subgroup and sensitivity analyses will explore sources of variation. As this study is based on published literature, ethical approval is not required. Findings will be disseminated through peer-reviewed publication and presentations at relevant academic conferences, contributing to evidence-based management strategies for refractory paediatric status epilepticus. CRD 420251153939.