Du Pont Daniel, Fenderson Rebecca, Hunter Krystal, Kuc Alexander, Carroll Gerard
Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PennsylvaniaUSA.
Department of Emergency Medicine, Cooper University Hospital, Camden, New JerseyUSA.
Prehosp Disaster Med. 2024 Apr;39(2):212-217. doi: 10.1017/S1049023X24000128. Epub 2024 Mar 7.
Opioid use disorder is a cause of significant morbidity and mortality. In order to reverse opioid overdose as quickly as possible, many institutions and municipalities have encouraged people with no professional medical training to carry and administer naloxone. This study sought to provide preliminary data for research into the rates of adverse effects of naloxone when administered by bystanders compared to Emergency Medical Services (EMS) personnel, since this question has not been studied previously.
This was a retrospective cohort study performed at an urban, tertiary, academic medical center that operates its own EMS service. A consecutive sample of patients presenting to EMS with opioid overdose requiring naloxone was separated into two groups based on whether naloxone was administered by bystanders or by EMS personnel. Each group was analyzed to determine the incidence of four pre-specified adverse events.
There was no significant difference in the rate of adverse events between the bystander (19%) and EMS (16%) groups (OR = 1.23; 95% CI, 0.63 - 2.32; P = .499) in this small sample. Based on these initial results, a study would need a sample size of 6,188 in order to reach this conclusion with 80% power. Similarly, there were no significant differences in the rates of any of the individual adverse events. Secondary analysis of patients' demographics showed differences between the two groups which generate hypotheses for further investigation of disparities in naloxone administration.
This preliminary study provides foundational data for further investigation of naloxone administration by bystanders. Adverse events after the prehospital administration of naloxone are rare, and future studies will require large sample sizes. These preliminary data did not demonstrate a statistically significant difference in adverse event rates when comparing naloxone administration by bystanders and EMS clinicians. This study provides data that will be useful for conducting further research on multiple facets of this topic.
阿片类药物使用障碍是导致严重发病和死亡的一个原因。为了尽快逆转阿片类药物过量情况，许多机构和市政当局鼓励未经专业医学培训的人员携带并使用纳洛酮。本研究旨在提供初步数据，以研究旁观者与紧急医疗服务（EMS）人员使用纳洛酮时的不良反应发生率，因为此前尚未对该问题进行过研究。
这是一项在一家运营自身EMS服务的城市三级学术医疗中心进行的回顾性队列研究。因阿片类药物过量而需要使用纳洛酮并被送往EMS的连续样本患者，根据纳洛酮是由旁观者还是EMS人员使用，被分为两组。对每组进行分析，以确定四种预先设定的不良事件的发生率。
在这个小样本中，旁观者组（19%）和EMS组（16%）的不良事件发生率没有显著差异（比值比 = 1.23；95%置信区间，0.63 - 2.32；P = 0.499）。基于这些初步结果，一项研究需要6188的样本量才能以80%的检验效能得出这一结论。同样，任何个体不良事件的发生率也没有显著差异。对患者人口统计学特征的二次分析显示两组之间存在差异，这为进一步研究纳洛酮使用方面的差异产生了假设。
这项初步研究为进一步调查旁观者使用纳洛酮提供了基础数据。院前使用纳洛酮后的不良事件很少见，未来的研究将需要大样本量。这些初步数据在比较旁观者和EMS临床医生使用纳洛酮时，未显示出不良事件发生率在统计学上有显著差异。本研究提供的数据将有助于对该主题的多个方面进行进一步研究。
