对于创伤性疼痛 (FORE-PAIN) 的芬太尼或乙胺试验:一项双盲多臂随机非劣势性试验的研究方案
Midas N de Grunt1, Nurseda Risvanoglu1, Johannes A Siegers1,2
1Amsterdam UMC, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.
Trials
|May 26, 2025
概括
这项研究比较了芬太尼和埃斯基他明用于医院前创伤性疼痛. 它评估了鼻内 (IN) 和静脉内 (IV) 给药的疗效和安全性,以指导紧急医疗服务.
科学领域:
- 紧急医疗 紧急医疗
- 疼痛管理 疼痛管理
- 临床试验 临床试验
背景情况:
- 芬太尼和胺是荷兰急性创伤性疼痛的标准医院前治疗方法.
- 缺乏静脉注射 (IV) 和鼻内注射 (IN) 芬太尼和埃斯基坦胺的比较有效性和安全性数据.
研究的目的:
- 与芬太尼IV相比,评估芬太尼IN,艾斯基坦胺IV和艾斯基坦胺IN的疗效和安全性.
- 在急性严重创伤性疼痛患者中,使用数值评分表 (NRS) 评估疼痛减轻.
主要方法:
- 进行了一次双盲,单中心,多臂,随机的非劣等性试验.
- 患有急性严重创伤性疼痛的成年人接受了芬太尼IV (1.0微克/公斤),芬太尼IN (1.25微克/公斤),乙胺IV (0.2毫克/公斤) 或乙胺IN (0.625微克/公斤).
- 主要终点是NRS得分在给药10分钟后减少.
主要成果:
- 主要终点分析将遵循治疗意图和每方案原则.
- 二级终点包括在其他时间点减少NRS,需要额外的止痛药,患者满意度和不良事件.
结论:
- 这项试验解决了医院前急诊实践的关键问题.
- 挑战包括医院前数据质量,人员研究经验和数据收集的时间限制.
- 在这种紧急情况下,需要推迟知情同意.
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