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小儿脐下手术中尾侧注射右美托咪定与鼻内注射右美托咪定的镇痛效果及安全性比较:一项随机对照试验。

Comparison of analgesic efficacy and safety of caudal dexmedetomidine versus intranasal dexmedetomidine in paediatric infraumbilical surgeries: A randomised controlled trial.

作者信息

Agarwal Ayushi, Shah Shreya B, Sinha Renu, Prasad Ganga, Prakash Kelika, Goel Prabudh

机构信息

From the Department of Anaesthesiology, Pain Medicine and Critical Care (AA, SBS, RS, GP, KP), and Department of Paediatric Surgery (PG), All India Institute of Medical Sciences, New Delhi, India (PG).

出版信息

Eur J Anaesthesiol. 2025 Oct 1;42(10):899-906. doi: 10.1097/EJA.0000000000002228. Epub 2025 Jun 27.

DOI:10.1097/EJA.0000000000002228
PMID:40574563
Abstract

BACKGROUND

The established analgesic efficacy and safety of dexmedetomidine in children has demonstrated a rise in its use and various administration routes have been explored. However, clinical comparisons between caudal and intranasal dexmedetomidine are lacking.

OBJECTIVES

We aimed to compare the analgesic efficacy, postanaesthesia recovery characteristics and side effects associated with caudal versus intranasal dexmedetomidine as an adjunct to a single-shot caudal block in paediatric infraumbilical surgeries.

DESIGN

A noninferiority randomised controlled trial.

SETTING

A tertiary care hospital from November 2022 to May 2024.

PATIENTS

Sixty-four children aged 1 to 8 years undergoing infraumbilical surgeries under general anaesthesia supplemented with caudal analgesia.

INTERVENTIONS

Patients were randomised to receive either caudal dexmedetomidine (1 ml kg -1 caudal 0.2% ropivacaine + 1 μg kg -1 caudal dexmedetomidine) or intranasal dexmedetomidine (1 ml kg -1 caudal 0.2% ropivacaine + 1 μg kg -1 intranasal dexmedetomidine).

MAIN OUTCOME MEASURES

The primary outcome was the duration of postoperative analgesia. Other outcomes assessed included postoperative pain scores, peri-operative analgesic consumption, peri-operative haemodynamics, postoperative recovery profile and adverse events for 24 h postoperatively.

RESULTS

The duration of postoperative analgesia in caudal and intranasal group was 527 ± 83 and 545 ± 90 min, respectively ( P   =  0.422). There was a comparable decrease in the intra-operative heart rate. The greater number of episodes of intra-operative hypotension in the caudal group ( P   =  0.016) did not warrant vasopressors. Children in the caudal group were more sedated until 2 h postsurgery following which the sedation scores in both the groups were equivalent. Postoperative pain scores, peri-operative analgesic consumption and the incidence of emergence delirium was comparable. No adverse events were reported in either group.

CONCLUSION

Intranasal dexmedetomidine can be considered a feasible analgesic adjunct to a single-injection caudal block in children undergoing infraumbilical surgeries associated with a smooth recovery profile and no associated adverse effects.

CLINICAL TRIAL REGISTRATION

Clinical Trial Registry of India (CTRI/2022/09/045492; http://www.ctri.nic.in ).

摘要

背景

右美托咪定在儿童中的镇痛效果和安全性已得到证实,其使用量有所增加,并且已经探索了多种给药途径。然而,缺乏关于骶管注射与鼻内给予右美托咪定的临床比较。

目的

我们旨在比较骶管注射与鼻内给予右美托咪定作为小儿脐下手术单次骶管阻滞辅助用药时的镇痛效果、麻醉后恢复特征及副作用。

设计

一项非劣效性随机对照试验。

地点

一家三级护理医院,时间为2022年11月至2024年5月。

患者

64名年龄在1至8岁之间、在全身麻醉并辅以骶管镇痛下行脐下手术的儿童。

干预措施

患者被随机分为接受骶管注射右美托咪定组(1 ml/kg骶管注射0.2%罗哌卡因 + 1 μg/kg骶管注射右美托咪定)或鼻内给予右美托咪定组(1 ml/kg骶管注射0.2%罗哌卡因 + 1 μg/kg鼻内给予右美托咪定)。

主要观察指标

主要观察指标为术后镇痛持续时间。评估的其他指标包括术后疼痛评分、围手术期镇痛药物用量、围手术期血流动力学、术后恢复情况及术后24小时内的不良事件。

结果

骶管注射组和鼻内给予组的术后镇痛持续时间分别为527 ± 83分钟和545 ± 90分钟(P = 0.422)。术中心率下降情况相似。骶管注射组术中低血压发作次数更多(P = 0.016),但无需使用血管升压药。骶管注射组儿童在术后2小时内镇静程度更高,之后两组的镇静评分相当。术后疼痛评分、围手术期镇痛药物用量及苏醒期谵妄发生率相当。两组均未报告不良事件。

结论

对于接受脐下手术的儿童,鼻内给予右美托咪定可被视为单次骶管阻滞可行的镇痛辅助用药,恢复过程平稳,且无相关不良反应。

临床试验注册

印度临床试验注册中心(CTRI/2022/09/045492;http://www.ctri.nic.in )

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