消化道内镜检查前口服劳拉西泮并不比安慰剂更能降低儿童的应激反应：一项双盲、随机、对照试验
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Oral Lorazepam is not Superior to Placebo for Lowering Stress in Children Before Digestive Endoscopy: A Double-Blind, Randomized, Controlled Trial
背景与目的
消化性内镜必须在安全、舒适的环境中进行。本课题组以前的研究已经证实，静脉镇静的质量常常受到术前应激的影响。故本研究旨在比较口服劳拉西泮和安慰剂对行消化内镜检查儿童唾液皮质醇反应的影响。次要目标是在以上干预措施下评估操作性疼痛和舒适度以及不良事件的发生情况。
方 法
将患者随机分为劳拉西泮组、安慰剂组和未用药组。入院时收集唾液，随机化后1h再次收集唾液。镇静方案包括咪达唑仑和芬太尼联合/不联合氯胺酮。采用护士评估患者舒适度评分表(NAPCOMS)对操作性疼痛进行评估。患者完成术后问卷调查。主要观察指标是皮质醇含量降低≥15 nmol/l的儿童的占比。
结 果
本研究共纳入101名参与者(54名女性)。劳拉西泮组、安慰剂组和未用药组皮质醇下降≥15 nmol/l所占比率分别为27.3%、35.3%和19.4%(p=0.356)。劳拉西泮组中位(IQR)NAPCOMS疼痛评分为3.0(0-6)，安慰剂组为4.4(0-6)，未用药组为3.4(3-4)(p=0.428)。感觉内镜检查过程非常舒适的儿童中，劳拉西泮组儿童的比例为75.9%，安慰剂组为41.9%，未用药的儿童为34.5%(p=0.013)。术中最常见的不良反应是短暂性心动过速，尤以劳拉西泮为主(62.5%，p=0.029)。
结 论
通过唾液皮质醇测定表明，口服劳拉西泮对患者术前应激没有影响，但与较高的舒适率相关。
原始文献摘要
Chennou F, Bonneau-Fortin A, Portolese O, et al. Oral Lorazepam is not Superior to Placebo for Lowering Stress in Children Before Digestive Endoscopy: A Double-Blind, Randomized, Controlled Trial.[J] .Paediatr Drugs, 2019
Background Digestive endoscopies must be performed within a safe and comfortable environment. We have previously shown that the quality of intravenous sedation is infuenced by preoperative stress.
Aim Our primary objective was to compare the effects of oral lorazepam and placebo on the salivary cortisol response of children undergoing a digestive endoscopy. Secondary objectives were the assessment of procedural pain and comfort as well as the occurrence of adverse events.
Methods Participants were randomized and received either lorazepam, placebo, or no premedication. Saliva was collected upon arrival at the hospital and 1 h following randomization. The sedation protocol included midazolam and fentanyl±ketamine. Procedural pain was evaluated with the Nurse Assessed Patient Comfort Score (NAPCOMS). Patients completed a postoperative questionnaire. The primary outcome was defned as the proportion of children having a cortisol decrease≥ 15 nmol/L.
Results 101 participants (54 females) were included. The rate of children having a cortisol decrease≥15 nmol/L was 27.3%, 35.3%, and 19.4% for lorazepam, placebo, and no premedication, respectively (p=0.356). The median (IQR) NAPCOMS pain score was 3.0 (0–6) for lorazepam, 4.4 (0–6) for placebo, and 3.4 (3–4) for no premedication (p=0.428). With lorazepam, 75.9% of children reported experiencing a comfortable procedure, compared with 41.9% taking placebo and 34.5% with no premedication (p=0.013). Transient tachycardia was the most frequent intraoperative adverse event, particularly with lorazepam (62.5%, p=0.029).
Conclusions Oral lorazepam had no effect on patients’ preoperative stress, as measured by salivary cortisol, but was associated with a higher rate of comfortable procedures.
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贵州医科大学高鸿教授课题组
翻译：何幼芹 编辑：何幼芹 审校：王贵龙