创伤性损伤引起的急性严重疼痛管理的镇痛：创伤中氯胺酮和吗啡比较的护理人员镇痛的随机对照试验（PACKMaN）研究方案。

Randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN).

机构信息

Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.

Critical Care Directorate, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.

出版信息

Scand J Trauma Resusc Emerg Med. 2023 Nov 24;31(1):84. doi: 10.1186/s13049-023-01146-1.

DOI:10.1186/s13049-023-01146-1

PMID:38001541

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10668487/

Abstract

BACKGROUND

Prehospital analgesia is often required after traumatic injury, currently morphine is the strongest parenteral analgesia routinely available for use by paramedics in the United Kingdom (UK) when treating patients with severe pain. This protocol describes a multi-centre, randomised, double blinded trial comparing the clinical and cost-effectiveness of ketamine and morphine for severe pain following acute traumatic injury.

METHODS

A two arm pragmatic, phase III trial working with two large NHS ambulance services, with an internal pilot. Participants will be randomised in equal numbers to either (1) morphine or (2) ketamine by IV/IO injection. We aim to recruit 446 participants over the age of 16 years old, with a self-reported pain score of 7 or above out of 10. Randomised participants will receive a maximum of 20 mg of morphine, or a maximum of 30 mg of ketamine, to manage their pain. The primary outcome will be the sum of pain intensity difference. Secondary outcomes measure the effectiveness of pain relief and overall patient experience from randomisation to arrival at hospital as well as monitoring the adverse events, resource use and cost-effectiveness outcomes.

DISCUSSION

The PACKMAN study is the first UK clinical trial addressing the clinical and cost-effectiveness of ketamine and morphine in treating acute severe pain from traumatic injury treated by NHS paramedics. The findings will inform future clinical practice and provide insights into the effectiveness of ketamine as a prehospital analgesia.

TRIAL REGISTRATION

ISRCTN, ISRCTN14124474. Registered 22 October 2020, https://www.isrctn.com/ISRCTN14124474.

摘要

背景

创伤后常需要院前镇痛，目前在英国（UK），当治疗严重疼痛的患者时，护理人员通常使用最强的吗啡进行治疗。本方案描述了一项多中心、随机、双盲试验，比较了氯胺酮和吗啡在急性创伤后严重疼痛中的临床和成本效益。

方法

采用与两家大型 NHS 救护车服务机构合作的两臂实用、III 期试验，并进行内部试点。参与者将按比例随机分配到静脉/IO 注射吗啡或氯胺酮（1）或（2）组。我们的目标是招募 446 名年龄在 16 岁以上的参与者，他们的自我报告疼痛评分在 10 分制中为 7 分或以上。随机分组的参与者将接受最大 20mg 吗啡或最大 30mg 氯胺酮治疗疼痛。主要结局将是疼痛强度差异的总和。次要结局测量从随机分组到入院时的疼痛缓解效果和整体患者体验，并监测不良事件、资源使用和成本效益结果。