鼻内注射氯胺酮和咪达唑仑用于小儿镇静的疗效：一项双盲随机临床试验。

Efficacy of intranasal ketamine and midazolam for pediatric sedation: A double-blind, randomized clinical trial.

作者信息

Khoshrang Hossein, Emir Alavi Cyrus, Rimaz Siamak, Mirmansouri Ali, Farzi Farnoush, Biazar Gelareh, Atrkarroushan Zahra, Sabet Khadem Nazanin

机构信息

Anesthesiology Research Center, Department of Anesthesiology, Alzahra Hospital, Guilan University of Medical Sciences , Rasht, Iran.

Department of Statistic, Guilan University of Medical Sciences, Rasht, Iran.

出版信息

Caspian J Intern Med. 2021 Fall;12(4):539-543. doi: 10.22088/cjim.12.4.539.

DOI:10.22088/cjim.12.4.539

PMID:34820060

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8590412/

Abstract

BACKGROUND

Pediatric patients feel significant fear and anxiety when undergoing surgeries. The ideal drug and its administration route have not been found yet. The aim of this study was to compare the efficacy and safety of intranasal (IN) ketamine and midazolam as premedication in children.

METHODS

We studied 71 eligible pediatric patients undergoing elective urologic surgeries, aged 2 to 6 years. The degree of sedation and separation scores was compared between the two groups. Additionally, hemodynamic parameters, before premedication, after induction of anesthesia, and during surgery were documented and compared between two groups. Postoperatively, any side effect was recorded as well.

RESULTS

Finally, the data from 71 children were analyzed. Recovery time was significantly longer in group K (ketamine) compared to group M (midazolam); 27.86±4.42 vs 38.19± 6.67 minutes respectively (P=0.01). No significant difference was observed in terms of sedation score between two groups of K & M; 3.29±0.78 vs 3 ±0.71 respectively (P=0.17), and not regarding separation score; 2.51±0.61 & 2.31±0.52 respectively (P=0.01). Vital signs were kept within the physiological limits in both groups with no marked fluctuations.

CONCLUSION

To produce sedation in young children, both midazolam and ketamine were effective and safe by IN route.

摘要

背景

儿科患者在接受手术时会感到极大的恐惧和焦虑。目前尚未找到理想的药物及其给药途径。本研究的目的是比较鼻内给予氯胺酮和咪达唑仑作为儿童术前用药的有效性和安全性。

方法

我们研究了71例年龄在2至6岁之间接受择期泌尿外科手术的合格儿科患者。比较了两组的镇静程度和分离评分。此外，记录并比较了两组患者术前、麻醉诱导后和手术期间的血流动力学参数。术后，还记录了任何副作用。

结果

最后，分析了71名儿童的数据。与咪达唑仑组（M组）相比，氯胺酮组（K组）的恢复时间明显更长；分别为27.86±4.42分钟和38.19±6.67分钟（P = 0.01）。两组在镇静评分方面未观察到显著差异；分别为3.29±0.78和3±0.71（P = 0.17），分离评分也无显著差异；分别为2.51±0.61和2.31±0.52（P = 0.01）。两组的生命体征均保持在生理范围内，无明显波动。