Effectiveness of acupuncture therapy for preventing emergence agitation in children: A protocol for systematic review and meta-analysis with trial sequential analysis.

Pain, autonomic distress, and emergence agitation occur commonly in children undergoing general anesthesia. While acupuncture therapy has been reported to effectively reduce such pain and autonomic distress in children, its effect in preventing emergence agitation remains unclear. Therefore, we will conduct a systematic review and meta-analysis with trial sequential analysis to evaluate the effect of acupuncture therapy in preventing emergence agitation in children undergoing general anesthesia. Methods and analysis This protocol was prepared according to the 2015 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for Protocols guidelines. We will conduct a search for randomized controlled trials that evaluated the effect of acupuncture therapy in preventing emergence agitation. The following databases will be searched for relevant articles: MEDLINE, CENTRAL, Embase, and Web of Science; four pre-registration sites will be accessed from inception to April 1, 2021. No language restrictions will be applied. Two authors will independently scan and select eligible studies, extract the data, and assess the risk of bias. The incidence of emergence agitation will be combined as a risk ratio with a 95% confidence interval using a random-effect model. The I2 statistics will be used to assess heterogeneity. We will evaluate the quality of the clinical trials using the Cochrane methodology and assess the quality of evidence using the Grading of Recommendation Assessment, Development, and Evaluation approach. If appropriate, a trial sequential analysis will be performed. Expected outcomes This meta-analysis will be the first to evaluate the effect of acupuncture therapy in preventing emergence agitation in children. The findings from this meta-analysis have the potential to reveal pivotal factors that affect the clinical effect of acupuncture therapy, thereby supporting the optimization of acupuncture therapy for emergence agitation. Protocol registration University Hospital Medical Information Network Clinical Trials Registry (UMIN000040775).