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氟哌啶醇-咪达唑仑与氟哌啶醇-氯胺酮用于控制谵妄患者躁动的随机临床试验

Haloperidol-Midazolam vs. Haloperidol-Ketamine in Controlling the Agitation of Delirious Patients; a Randomized Clinical Trial.

作者信息

Aghili Mehrad, AkhavanHejazi HamidReza, Naderpour Zeinab, Vahidi Elnaz, Saeedi Morteza

机构信息

Department of Emergency Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Department of Internal Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Arch Acad Emerg Med. 2023 Aug 26;11(1):e61. doi: 10.22037/aaem.v11i1.2095. eCollection 2023.

DOI:10.22037/aaem.v11i1.2095
PMID:37840867
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10568945/
Abstract

INTRODUCTION

Agitation management in delirious patients is crucial in a crowded emergency department (ED) for both patient and personnel safety. Benzodiazepines, antipsychotics, and newly derived ketamine are among the most commonly used drugs in controlling these cases. This study aimed to compare the effectiveness of haloperidol-midazolam with haloperidol-ketamine combination in this regard.

METHODS

In this double-blind randomized clinical trial, delirious patients with agitation in ED were randomly assigned to a group: group A: haloperidol 2.5 mg IV and midazolam 0.05 mg/kg IV or group B: haloperidol 2.5 mg IV and ketamine 0.5 mg/kg IV. Sedative effects as well as side effects at 0, 5, 10, 15, 30 minutes and 1, 2, 4 hours after the intervention were compared between the 2 groups.

RESULTS

We enrolled 140 cases with Altered Mental Status Score (AMSS)≥+2 and mean age of 52.819.4 years (78.5% male). Agitation was significantly controlled in both groups (p<0.05). In group B, AMSS score was more significantly and rapidly reduced 5 (p = 0.021), 10 (p = 0.009), and 15 (p = 0.034) minutes after drug administration. After intervention, oxygen saturation was significantly decreased in group A 5 (p = 0.031) and 10 (p = 0.019) minutes after baseline. Time required to the maximum effect was significantly lower in group B versus group A (p=0.014). Less patients in group B had major side effects (p=0.018) and needed physical restraint (p=0.001).

CONCLUSIONS

Haloperidol-ketamine can control agitation in delirium more rapidly than haloperidol-midazolam. This combination had lower adverse events with lower need for physical restraint.

摘要

引言

对于拥挤的急诊科而言,谵妄患者的躁动管理对患者和医护人员的安全都至关重要。苯二氮卓类药物、抗精神病药物以及新推出的氯胺酮是控制此类情况最常用的药物。本研究旨在比较氟哌啶醇 - 咪达唑仑与氟哌啶醇 - 氯胺酮联合用药在这方面的有效性。

方法

在这项双盲随机临床试验中,急诊科有躁动的谵妄患者被随机分为两组:A组:静脉注射氟哌啶醇2.5毫克和咪达唑仑0.05毫克/千克;B组:静脉注射氟哌啶醇2.5毫克和氯胺酮0.5毫克/千克。比较两组在干预后0、5、10、15、30分钟以及1、2、4小时的镇静效果和副作用。

结果

我们纳入了140例精神状态改变评分(AMSS)≥ +2且平均年龄为52.8 ± 19.4岁(78.5%为男性)的患者。两组的躁动均得到显著控制(p < 0.05)。在B组中,给药后5分钟(p = 0.021)、10分钟(p = 0.009)和15分钟(p = 0.034)时,AMSS评分降低更为显著且迅速。干预后,A组在基线后5分钟(p = 0.031)和10分钟(p = 0.019)时血氧饱和度显著下降。B组达到最大效果所需时间显著短于A组(p = 0.014)。B组出现严重副作用的患者较少(p = 0.018),且需要身体约束的患者也较少(p = 0.001)。

结论

氟哌啶醇 - 氯胺酮比氟哌啶醇 - 咪达唑仑能更迅速地控制谵妄患者的躁动。这种联合用药的不良事件较少,对身体约束的需求也较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e50/10568945/33b55c2df0f7/aaem-11-e61-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e50/10568945/33b55c2df0f7/aaem-11-e61-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e50/10568945/33b55c2df0f7/aaem-11-e61-g001.jpg

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