Effect of family-centred perioperative care for anaesthesia on the incidence of emergence delirium in children after surgery: a protocol for a randomised controlled trial in China.

Abstract

Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalisation periods, escalated healthcare expenses and increased incidence of postoperative maladaptive behaviours (POMBs). Well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED are notably absent. Therefore, this study aimed to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children compared with routine anaesthesia. This multicentre, prospective, open-label, randomised controlled clinical trial will enrol a total of 444 children aged 2-6 years undergoing elective short surgery (estimated duration ≤2 h). According to the stratification factors of surgical types (ophthalmology, ear, nose and throat (Oph&ENT) and non-Oph&ENT surgeries), patients will be randomly allocated into two groups in a 1:1 ratio. For the FPCA group (group F), both children and parents will receive FPCA (including video education, mask practice, electronic pamphlet, distraction strategies and parental presence), without sedatives before surgery. For the routine anaesthesia group (group R), both children and parents will receive routine preoperative education and anaesthesia, and preoperative sedatives (such as oral midazolam or intranasal dexmedetomidine) will be recommended. The primary outcome is the incidence of ED. Secondary outcomes include the severity of ED, incidence of POMBs, cognitive function, quality of sleep and life, preoperative anxiety, compliance with anaesthesia induction and postoperative pain score. Logistic regression will be applied to compare differences in primary and secondary outcomes between groups, and patients' age, sex, and body mass index will be considered as covariates in baseline measurements. This study protocol was approved by the Ethics Committee of The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University. Results will be disseminated via peer-reviewed journals, academic conferences and mass media. Recruitment began in October 2023. NCT06092671.