Khodadad Ahmad, Aflatoonian Majid, Jalilian Rozita, Babaei Nazanin, Motamed Farzaneh, Ebrahime Soltani Alireza, Rasoolzadeh Behnaz, Motavasselian Fatemeh, Rezaei Nima
Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
Acta Med Iran. 2016 Sep;54(9):576-582.
Upper endoscopy is a common procedure for the diagnosis and treatment of upper digestive tract diseases. The increasing number of pediatric gastrointestinal procedures has led to increasing attention on the safety and efficacy of medications used for sedation during the procedure. This randomized blinded interventional study was designed to compare the effect of oral midazolam with intravenous (IV) midazolam as a sedative medication in 119 children undergoing endoscopy. The mean time to sedation was 2.2±0.7 in IV midazolam group and 30.9±0 in oral midazolam group which was statistically significant difference between two groups. Separation from parents in oral midazolam group was as follow: 2 patients were high resistant (3.5%), 2 patients were resisted first and then relaxed (3.5%) and 55 patients were separated from their parents without any resistance (93%); whereas in IV midazolam group, 8 patients were high resistant (13.3%), 29 patients were relatively resistant (48.3%) and 23 patients were separated from their parents without any resistance (38.3%) that shows significant differences between the two groups. In terms of patient comfort during endoscopy, there was also a significant difference between the two groups. In oral midazolam, group parents were more consent, compared with the other group. The present study showed that oral midazolam is a safe and effective sedation during upper endoscopy in pediatrics. Oral midazolam reducing patients' anxiety during separation from parents leads the easy use of endoscopy and comfort of patients during endoscopy as compared with IV midazolam. Oral or IV midazolam were not able to put most patients in deep sedation level.
上消化道内镜检查是诊断和治疗上消化道疾病的常见方法。儿科胃肠道手术数量的增加使得人们越来越关注手术期间用于镇静的药物的安全性和有效性。这项随机双盲干预研究旨在比较口服咪达唑仑与静脉注射(IV)咪达唑仑作为镇静药物对119名接受内镜检查儿童的效果。静脉注射咪达唑仑组的平均镇静时间为2.2±0.7,口服咪达唑仑组为30.9±0,两组之间存在统计学显著差异。口服咪达唑仑组与父母分离的情况如下:2名患者高度抗拒(3.5%),2名患者先抗拒后放松(3.5%),55名患者与父母顺利分离无任何抗拒(93%);而在静脉注射咪达唑仑组,8名患者高度抗拒(13.3%),29名患者相对抗拒(48.3%),23名患者与父母顺利分离无任何抗拒(38.3%),两组之间存在显著差异。在内镜检查期间患者的舒适度方面,两组之间也存在显著差异。与另一组相比,口服咪达唑仑组的父母更易接受。本研究表明,口服咪达唑仑在儿科上消化道内镜检查期间是一种安全有效的镇静方法。与静脉注射咪达唑仑相比,口服咪达唑仑在患者与父母分离期间减轻了焦虑,使得内镜检查更易于实施且患者在内镜检查期间更舒适。口服或静脉注射咪达唑仑均无法使大多数患者达到深度镇静水平。