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奈福泮在剖腹术后患者自控镇痛中的阿片类药物节省效应及安全性:一项随机、双盲研究。

Opioid sparing effect and safety of nefopam in patient controlled analgesia after laparotomy: A randomized, double blind study.

作者信息

Jin Hyun Seung, Kim Yong Chul, Yoo Yongjae, Lee Changsoon, Cho Chan Woo, Kim Won-Joong

机构信息

Department of Anaesthesia and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.

Department of Anaesthesia and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea

出版信息

J Int Med Res. 2016 Aug;44(4):844-54. doi: 10.1177/0300060516650783. Epub 2016 Jun 29.

DOI:10.1177/0300060516650783
PMID:27358262
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5536619/
Abstract

OBJECTIVES

A double-blind randomised study to evaluate the opioid sparing effect and safety of nefopam when administered via intravenous patient controlled analgesia (PCA) with fentanyl.

METHODS

Patients planned for elective open laparotomy, were randomly assigned to receive into fentanyl 25 µg/ml (SF group) or nefopam 2.4 mg/ml plus fentanyl 25 µg/ml (NF group). Patients were assessed before surgery and for 24 h postoperatively.

RESULTS

Total PCA fentanyl consumption was significantly lower in the NF group (n = 35) than the SF group (n = 36). Pain scores were significantly lower and patients' satisfaction with treatment significantly better in the NF group than the SF group. Dry mouth and dizziness were significantly more frequent in the NF group than the SF group. There were no other statistically significant between-group differences in the incidence of adverse events.

CONCLUSIONS

Intravenous PCA using nefopam + fentanyl following laparotomy has an opioid sparing effect and is associated with a low incidence of some of the typical opioid related adverse events.

TRIAL REGISTRY

Clinicaltrials.gov Registration No: NCT02596269.

摘要

目的

一项双盲随机研究,旨在评估奈福泮与芬太尼联合用于静脉自控镇痛(PCA)时的阿片类药物节省效应及安全性。

方法

计划接受择期开腹手术的患者,被随机分配接受25μg/ml芬太尼(SF组)或2.4mg/ml奈福泮加25μg/ml芬太尼(NF组)。在手术前及术后24小时对患者进行评估。

结果

NF组(n = 35)的PCA芬太尼总消耗量显著低于SF组(n = 36)。NF组的疼痛评分显著更低,患者对治疗的满意度显著高于SF组。NF组口干和头晕的发生率显著高于SF组。两组间不良事件发生率在其他方面无统计学显著差异。

结论

剖腹手术后使用奈福泮 + 芬太尼进行静脉PCA具有阿片类药物节省效应,且某些典型的阿片类药物相关不良事件发生率较低。

试验注册

Clinicaltrials.gov注册号:NCT02596269。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/ed473c13fa67/10.1177_0300060516650783-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/21f5021ec45e/10.1177_0300060516650783-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/884b21b49e02/10.1177_0300060516650783-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/b2102618c0d4/10.1177_0300060516650783-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/439a8ed6a937/10.1177_0300060516650783-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/ed473c13fa67/10.1177_0300060516650783-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/21f5021ec45e/10.1177_0300060516650783-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/884b21b49e02/10.1177_0300060516650783-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/b2102618c0d4/10.1177_0300060516650783-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/439a8ed6a937/10.1177_0300060516650783-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2888/5536619/ed473c13fa67/10.1177_0300060516650783-fig5.jpg

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