Comparison of the antiemetic effect of ramosetron and combined ramosetron and midazolam in children: A double-blind, randomised clinical trial

摘要

Context Postoperative nausea and vomiting remains a clinically important problem after strabismus surgery in children. Objective To study the benefit of adding midazolam to ramosetron on the incidence of postoperative nausea, retching or vomiting and on the incidence of postoperative agitation. Design A randomised, double-blind comparison. Setting The operating theatre suite and day care unit of Seoul National University Hospital. The study period was January to December 2010. Patients In total, 405 paediatric patients (aged 4-12 years) undergoing strabismus surgery were enrolled and randomly assigned to one of two groups, ramosetron or ramosetron with midazolam. Intervention Patients received either ramosetron 6mgkg -1 or ramosetron 6mgkg -1 and midazolam 0.1mgkg -1 prior to induction of anaesthesia. Main outcome measures The incidences of nausea, retching or vomiting in the first 48 h after surgery, and the incidence of emergence agitation in the post-anaesthetic care unit. Result The incidences of nausea, retching or vomiting during the first and second 24-h periods after surgery were similar in the two groups. There was a small, clinically insignificant reduction in delirium scores in the ramosetron with midazolam group. Conclusion Adding midazolam to ramosetron had no advantages over ramosetron alone in reducing the incidence of postoperative nausea and vomiting in children undergoing strabismus surgery.