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

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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.<h4>Ethics and dissemination</h4>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.<h4>Prospero registration number</h4>CRD 420251153939.