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院前髋部骨折快速镇痛(RAPID):一项随机可行性研究的结果

Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study.

作者信息

Jones Jenna K, Evans Bridie A, Fegan Greg, Ford Simon, Guy Katy, Jones Sian, Keen Leigh, Khanom Ashrafunnesa, Longo Mirella, Pallister Ian, Rees Nigel, Russell Ian T, Seagrove Anne C, Watkins Alan, Snooks Helen A

机构信息

1Swansea University Medical School, Swansea, UK.

Swansea Bay University Health Board, Swansea, UK.

出版信息

Pilot Feasibility Stud. 2019 Jun 12;5:77. doi: 10.1186/s40814-019-0454-1. eCollection 2019.

Abstract

BACKGROUND

In managing hip fracture, effective pain relief before admission to hospital is difficult without risking side effects. Although emergency departments routinely use fascia iliaca compartment block (FICB), there has been little evaluation of its use by paramedics before hospital admission. We aimed to assess whether a multi-centre randomised trial to evaluate FICB was feasible.

METHODS

Volunteer paramedics used scratchcards to allocate patients with hip fracture at random between FICB and pain relief as usual. Primary outcomes were mortality and quality of life. We also measured adverse events, costs, final diagnosis, length of stay in hospital, pain scores and quality of care and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on the recruitment of paramedics and patients, delivery of FICB, retrieval of outcome data, safety, acceptability, and diagnostic accuracy of hip fracture.

RESULTS

We effectively met all progression criteria: we recruited 19 paramedics who randomly allocated 71 patients between trial arms between 28 June 2016 and 31 July 2017; 57 (31 experimental arm, 26 usual care arm, 80% overall) retrospectively consented to follow-up. Just over half (17/31) of experimental participants received FICB; all others had contraindications, including nine taking anticoagulants. Four of the 31 participants assigned FICB and six of the 26 assigned usual care died within 6 months of hospital admission. Serious adverse events were also similar: 3/35 experimental versus 4/36 in usual care. Paramedics' recognition of hip fracture had sensitivity of 49/64 (77%) with a positive predictive value of 46/57 (81%). We received quality of life questionnaires for 30 of 49 patients (61%) at 1 month and 12 of 17 (71%) at 6 months. Patient satisfaction was similar: experimental mean 3.4 ( = 20) versus 3.5 ( = 13) for usual care.

CONCLUSIONS

RAPID met all progression criteria within reasonable limits. As equipoise remains, we plan to undertake a fully powered multi-centre trial to test clinical and cost effectiveness of paramedic-administered FICB at the scene of hip fracture.

TRIAL REGISTRATION

ISRCTN 60065373 sought 5 November 2015.

摘要

背景

在处理髋部骨折时,在不冒副作用风险的情况下,入院前有效缓解疼痛很困难。尽管急诊科常规使用髂筋膜室阻滞(FICB),但对于护理人员在入院前使用该方法的评估却很少。我们旨在评估一项评估FICB的多中心随机试验是否可行。

方法

志愿者护理人员使用刮刮卡将髋部骨折患者随机分配至FICB组和常规疼痛缓解组。主要结局指标为死亡率和生活质量。我们还测量了不良事件、成本、最终诊断、住院时间、疼痛评分和护理质量,并通过访谈收集了患者对该方法可接受性的定性数据,以及通过焦点小组收集了护理人员的相关数据。我们预先设定了基于护理人员和患者的招募情况、FICB的实施情况、结局数据的获取情况、安全性、可接受性以及髋部骨折诊断准确性来决定是否推进至全面试验的标准。

结果

我们有效地满足了所有推进标准:我们招募了19名护理人员,他们在2016年6月28日至2017年7月31日期间将71例患者随机分配至试验组;57例(试验组31例,常规护理组26例,总体为80%)患者回顾性同意进行随访。试验组中略超过一半(17/31)的参与者接受了FICB;其他所有参与者均有禁忌证,包括9例正在服用抗凝剂的患者。31例被分配接受FICB的参与者中有4例,26例被分配接受常规护理的参与者中有6例在入院后6个月内死亡。严重不良事件也相似:试验组35例中有3例,常规护理组36例中有4例。护理人员对髋部骨折的识别敏感性为49/64(77%),阳性预测值为46/57(81%)。我们收到了49例患者中30例(61%)在1个月时的生活质量问卷,以及17例中12例(71%)在6个月时的问卷。患者满意度相似:试验组平均为3.4(n = 20),常规护理组为3.5(n = 13)。

结论

RAPID在合理范围内满足了所有推进标准。由于仍保持均衡,我们计划进行一项全面的多中心试验,以测试护理人员在髋部骨折现场实施FICB的临床和成本效益。

试验注册

ISRCTN 60065373,于2015年11月5日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0900/6560881/8c9a044a4f12/40814_2019_454_Fig1_HTML.jpg

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