Arhami Dolatabadi Ali, Mohammadian Aida, Kariman Hamid
1. Emergency Department, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Emerg (Tehran). 2018;6(1):e24. Epub 2018 Apr 16.
Finding a fast-acting compound with minimal side-effects to induce a safe and efficient analgesia with short or medium duration of action is of great interest in the emergency department. The present study has been designed with the aim of comparing the effect of midazolam + fentanyl + lidocaine combination with midazolam + fentanyl + placebo in pain management of anterior shoulder dislocation reduction.
The present two-arm parallel double-blind randomized controlled trial was performed on patients who presented to emergency department with anterior shoulder dislocation. Patients were randomly allocated to the 2 treatment groups of midazolam + fentanyl + placebo (double-drug group) and midazolam + fentanyl + intravenous (IV) lidocaine (triple-drug group). Then outcomes such as treatment success rate and side-effects following prescription of drugs were compared between the 2 groups.
100 patients were included in the present study (50 patients in each group; mean age of the studied patients 27.3±8.9 years; 93.0% male). Using the double-drug regimen led to 35 (70%) cases of complete analgesia, while this rate in the triple-drug group was 41 (82%) cases (p=0.16). The calculated number needed to treat was 9 cases. This means that about one in every 9 patients in treatment arm will benefit from the treatment. The most important side-effects observed included dysrhythmia (1 patient in double drug and 1 patient in triple-drug group), apnea (2 patients in each group) and SPO2<90% (2 patients in triple-drug group) (p=0.78). Number needed to harm was 25 cases. In other words, for each 25 patients treated with the triple drug regimen, 1 case of SPO2<90% is observed.
Findings of the present study showed that adding IV lidocaine to IV midazolam + fentanyl drug combination does not provide additional analgesia in sedation for anterior shoulder reduction.
在急诊科，寻找一种起效快、副作用小，能诱导安全有效且作用时间短或中等的镇痛药物备受关注。本研究旨在比较咪达唑仑+芬太尼+利多卡因组合与咪达唑仑+芬太尼+安慰剂在前肩脱位复位疼痛管理中的效果。
本双臂平行双盲随机对照试验针对因前肩脱位就诊于急诊科的患者进行。患者被随机分配至咪达唑仑+芬太尼+安慰剂（双药组）和咪达唑仑+芬太尼+静脉注射（IV）利多卡因（三药组）这两个治疗组。然后比较两组用药后的治疗成功率和副作用等结果。
本研究纳入了100例患者（每组50例；研究患者的平均年龄为27.3±8.9岁；男性占93.0%）。使用双药方案导致35例（70%）完全镇痛，而三药组这一比例为41例（82%）（p = 0.16）。计算得出的治疗所需人数为9例。这意味着治疗组中每9名患者约有1名将从治疗中获益。观察到的最重要副作用包括心律失常（双药组1例，三药组1例）、呼吸暂停（每组2例）和SPO2<90%（三药组2例）（p = 0.78）。伤害所需人数为25例。换句话说，每25例接受三药方案治疗的患者中，会观察到1例SPO2<90%。
本研究结果表明，在静脉注射咪达唑仑+芬太尼药物组合中添加静脉注射利多卡因在前肩复位镇静中并未提供额外的镇痛效果。
