Liacouras C A, Mascarenhas M, Poon C, Wenner W J
Division of Gastroenterology and Nutrition, The Children's Hospital of Philadelphia, Pennsylvania 19104, USA.
Gastrointest Endosc. 1998 Jun;47(6):455-60. doi: 10.1016/s0016-5107(98)70244-5.
This study was performed to evaluate the effect of midazolam, as premedication before intravenous conscious sedation, on preprocedural, procedural, and post-procedural patient comfort and anxiety in children undergoing endoscopy.
A placebo-controlled, double-blind, randomized study was conducted in 123 children (age 7.75 +/- 4.46 years, 56% male) using oral midazolam (0.5 mg/kg, maximum 20 mg) as a premedication before insertion of an intravenous access device (i.v.) and upper endoscopy. Patients were evaluated with regard to changes in vital signs, level of sedation during i.v. placement, level of pre- and post-procedure conscious sedation, ease of separation from parents, ease and duration of procedure, recovery time, and amnesia to objects shown before i.v. placement and immediately before the start of the procedure.
A significant difference was noted in the study group for the following parameters: level of sedation for i.v. placement (p < 0.0001), pre-procedural sedation (p < 0.001), ease of i.v. insertion (p < 0.003), ease of separation from parents (p = 0.022), and ease of the nursing personnel's ability to monitor the patient during the procedure (p = 0.0012). The patient's amnesia to an object shown immediately before beginning the endoscopy was increased (p < 0.001). Patients and parents were also more satisfied with the procedure process (p < 0.05). No significant difference was noted with regard to the length or performance of the procedure or recovery time or in the dose of i.v. medication required for successful completion of the endoscopy.
Oral midazolam is an effective and safe premedication for children undergoing upper endoscopy and should be used in all anxious children and in patients previously judged to be difficult to sedate.
本研究旨在评估咪达唑仑作为静脉清醒镇静前的术前用药，对接受内镜检查的儿童术前、术中及术后的舒适度和焦虑程度的影响。
对123名儿童（年龄7.75±4.46岁，56%为男性）进行了一项安慰剂对照、双盲、随机研究，使用口服咪达唑仑（0.5mg/kg，最大20mg）作为插入静脉通路装置（i.v.）和上消化道内镜检查前的术前用药。对患者的生命体征变化、静脉置管期间的镇静水平、术前和术后清醒镇静水平、与父母分离的难易程度、操作的难易程度和持续时间、恢复时间以及对静脉置管前和即将开始操作前展示的物品的遗忘情况进行了评估。
研究组在以下参数方面存在显著差异：静脉置管的镇静水平（p<0.0001）、术前镇静（p<0.001）、静脉穿刺的难易程度（p<0.003）、与父母分离的难易程度（p=0.022）以及护理人员在操作过程中监测患者的难易程度（p=0.0012）。患者对内镜检查开始前立即展示的物品的遗忘程度增加（p<0.001）。患者和家长对操作过程也更满意（p<0.05）。在操作的长度或执行情况、恢复时间或成功完成内镜检查所需的静脉用药剂量方面未发现显著差异。
口服咪达唑仑对于接受上消化道内镜检查的儿童是一种有效且安全的术前用药，应在所有焦虑儿童以及先前判断为难以镇静的患者中使用。
