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临床试验/NCT03537001
NCT03537001已完成不适用

Use of Inhaled Methoxyflurane (Penthrox®) as an Analgesic in Extra-hospital Traumatology at EMS37

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change of traumatic acute pain level between baseline and 5 minutes

研究概览

简要总结

In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.

An optimization of the management of pain in urgency is therefore still necessary.

A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.

The purpose of this study is to answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?

详细描述

In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.

An optimization of the management of pain in urgency is therefore still necessary.

A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.

Methoxyflurane (Penthrox®) is a single-use inhalation non-opioid analgesic for the management of moderate to severe traumatic pain. This treatment has been used in New Zealand and Canada for over 20 years for the management of acute pain in adults and children. It was granted marketing authorization in Europe in 2016 and has been marketed in France since 2017.

The purpose of this study is:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Conscious Patient
  • Age ≥ 18 years
  • Acute pain only of traumatic origin
  • Pain > 4 on a visual numerical scale (VNS)
  • Stable hemodynamic conditions (PA> 90/60)
  • Non Inclusion Criteria:
  • Pregnant or nursing woman
  • Patient who has already received analgesics
  • Patient benefiting from an intravenous approach for analgesia
  • Known renal or hepatic disease
  • Hypersensitivity to fluorinated anesthetics or history of malignant hyperthermia of the patient or family.
  • Respiratory distress
  • Patient who objected to the processing of his data

排除标准

  • Intravenous injection for analgesia

结局指标

主要结局

Change of traumatic acute pain level between baseline and 5 minutes

时间窗: Baseline, 5 minutes

Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).

次要结局

  • Change of traumatic acute pain level between 0 and15 minutes(Baseline, 15 minutes)
  • Pain extinction duration(Baseline, 10 & 15 minutes)
  • Medical team level of satisfaction(30 minutes)
  • Change of traumatic acute pain level between baseline and 10 minutes(Baseline, 10 minutes)
  • Penthrox tolerance(Through study completion, an average of 30 minutes)
  • Patient level of satisfaction(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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