Adjuvant nefopam versus standard of care in mechanically ventilated surgical critically ill patients: A randomized, double-blind controlled study

IF 3.7 3区医学 Q1 ANESTHESIOLOGY

Anaesthesia Critical Care & Pain Medicine Pub Date : 2025-05-01 DOI:10.1016/j.accpm.2025.101518

Mohammed Gamal Abdelraouf , Samar Farghali Farid , Ahmed Mohammed Mukhtar , Nirmeen Ahmed Sabry

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引用次数: 0

Abstract

Background

Multimodal analgesia, through combining different classes of analgesia that target pain pathways with different mechanisms reduces opioid consumption. This study aimed to determine the impact of adjunct nefopam infusion on opiate consumption when added to standard-of-care analgesia and sedation in mechanically ventilated critically ill patients.

Methods

This was a prospective, randomized, active control, double-blind study. Patients admitted to the ICU, being mechanically ventilated and candidates for analgesia and sedation protocols were randomized to the intervention group (n = 30) or to the control group (n = 30).

The primary outcome was the cumulative dose of fentanyl in the first 24 h after inclusion. The secondary outcomes were the proportion of patients with positive pain scores, change in mean arterial pressure (MAP), heart rate (HR), ICU mortality, and others.

Results

A total of 60 patients were included in the final analysis; median (Q1, Q3) cumulative fentanyl consumption mcg/24 h was significantly (p = 0.001) lower in the intervention group compared to the control group 1300 (575, 2087.5) vs. 2400 (1612.5, 2665) mcg/24 h respectively. Pain and sedation scores were comparable between the two study groups. ICU mortality was 25 (83.3%) in the intervention group vs. 20 (66.7%) in the control group (P = 0.136).

Conclusions

Nefopam was found to be an effective non-opioid option for analgesia in mechanically ventilated surgical and trauma critically ill patients, and more studies are needed to evaluate its safety.

Clinical trial registry and number

ClinicalTrials.gov (identifier: NCT05071352).

查看原文本刊更多论文

机械通气外科危重患者的辅助护理与标准护理：一项随机、双盲对照研究

多模式镇痛，通过结合不同类型的镇痛，以不同的机制靶向疼痛通路，减少阿片类药物的消耗。本研究旨在确定机械通气危重患者在标准护理镇痛和镇静中辅助输注尼福泮对阿片类药物消耗的影响。方法前瞻性、随机、主动对照、双盲研究。在ICU住院、机械通气和拟实施镇痛镇静方案的患者随机分为干预组（n = 30）和对照组（n = 30）。主要终点是纳入后24小时内芬太尼的累积剂量。次要结局是疼痛评分阳性的患者比例、平均动脉压变化（MAP）、心率（HR）、ICU死亡率等。结果共纳入60例患者；干预组中位（Q1, Q3）芬太尼累积消耗量mcg/24 h显著（p = 0.001）低于对照组，分别为1300（575,2087.5）和2400 (1612.5,2665)mcg/24 h。两个研究组的疼痛和镇静评分具有可比性。干预组ICU病死率为25例（83.3%），对照组为20例（66.7%）（P = 0.136）。结论奈氟泮是机械通气外科及创伤危重患者有效的非阿片类镇痛选择，其安全性有待进一步研究。临床试验注册和号码clinicaltrials .gov（标识符：NCT05071352）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Anaesthesia Critical Care & Pain Medicine ANESTHESIOLOGY-

CiteScore

6.70

自引率

5.50%

发文量

150

审稿时长

18 days

期刊介绍： Anaesthesia, Critical Care & Pain Medicine (formerly Annales Françaises d''Anesthésie et de Réanimation) publishes in English the highest quality original material, both scientific and clinical, on all aspects of anaesthesia, critical care & pain medicine.