Research Department, Prehospital Emergency Medical Service, Central Denmark Region, Olof Palmes Allé 34, 8200, Aarhus N, Denmark.
Department of Anaesthesiology, Regional Hospital of Horsens, Horsens, Denmark.
Scand J Trauma Resusc Emerg Med. 2019 Feb 7;27(1):11. doi: 10.1186/s13049-019-0588-4.
Prehospital acute pain is a frequent symptom that is often inadequately managed. The concerns of opioid induced side effects are well-founded. To ensure patient safety, ambulance personnel are therefore provided with treatment protocols with dosing restrictions, however, with the concomitant risk of insufficient pain treatment of the patients. The aim of this study was to investigate the impact of a liberal intravenous fentanyl treatment protocol on efficacy and safety measures.
A two-armed, cluster-randomised trial was conducted in the Central Denmark Region over a 1-year period. Ambulance stations (stratified according to size) were randomised to follow either a liberal treatment protocol (3 μg/kg) or a standard treatment protocol (2 μg/kg). The primary outcome was the proportion of patients with sufficient pan relief (numeric rating scale (NRS, 0-10) < 3) at hospital arrival. Secondary outcomes included abnormal vital parameters as proxy measures of safety. A multi-level mixed effect logistic regression model was applied.
In total, 5278 patients were included. Ambulance personnel following the liberal protocol administered higher doses of fentanyl [117.7 μg (95% CI 116.7-118.6)] than ambulance personnel following the standard protocol [111.5 μg (95% CI 110.7-112.4), P = 0.0001]. The number of patient with sufficient pain relief at hospital arrival was higher in the liberal treatment group than the standard treatment group [44.0% (95% CI 41.8-46.1) vs. 37.4% (95% CI 35.2-39.6), adjusted odds ratio 1.47 (95% CI 1.17-1.84)]. The relative decrease in NRS scores during transport was less evident [adjusted odds ratio 1.18 (95% CI 0.95-1.48)]. The occurrences of abnormal vital parameters were similar in both groups.
Liberalising an intravenous fentanyl treatment protocol applied by ambulance personnel slightly increased the number of patients with sufficient pain relief at hospital arrival without compromising patient safety. Future efforts of training ambulance personnel are needed to further improve protocol adherence and quality of treatment.
ClinicalTrials.gov ( NCT02914678 ). Date of registration: 26th September, 2016.
院前急性疼痛是一种常见症状，往往得不到充分治疗。人们对阿片类药物引起的副作用的担忧是有充分依据的。为了确保患者安全，救护车人员因此被提供了剂量限制的治疗方案，但这也伴随着患者疼痛治疗不足的风险。本研究旨在调查一种宽松的静脉注射芬太尼治疗方案对疗效和安全措施的影响。
在丹麦中部地区进行了一项为期 1 年的、两臂、整群随机试验。根据规模对救护车站进行分层随机分组，分别遵循宽松治疗方案（3μg/kg）或标准治疗方案（2μg/kg）。主要结局是到达医院时疼痛缓解充分（数字评分量表（NRS，0-10）<3）的患者比例。次要结局包括异常生命参数作为安全性的替代指标。应用多级混合效应逻辑回归模型。
共纳入 5278 例患者。采用宽松方案的救护人员给予芬太尼的剂量较高[117.7μg（95%CI 116.7-118.6）]，而采用标准方案的救护人员给予芬太尼的剂量较低[111.5μg（95%CI 110.7-112.4），P=0.0001]。在宽松治疗组中，到达医院时疼痛缓解充分的患者比例高于标准治疗组[44.0%（95%CI 41.8-46.1）比 37.4%（95%CI 35.2-39.6），调整后的优势比 1.47（95%CI 1.17-1.84）]。在转运过程中 NRS 评分的相对下降不那么明显[调整后的优势比 1.18（95%CI 0.95-1.48）]。两组异常生命参数的发生情况相似。
放宽救护车人员应用的静脉注射芬太尼治疗方案，略微增加了到达医院时疼痛缓解充分的患者数量，同时不影响患者安全。需要进一步努力培训救护车人员，以进一步提高方案的遵守程度和治疗质量。
ClinicalTrials.gov（NCT02914678）。注册日期：2016 年 9 月 26 日。
