Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change of traumatic acute pain level between baseline and 15 minutes
研究概览
简要总结
Study of traumatized patients treated in emergency departments of Tours, seeking to optimize the management of trauma pain in an inpatient setting, with the opportunity to integrate inhaled methoxyflurane (Penthrox®) into the arsenal analgesics useful in the analgesic protocol of the Reception and Orientation Nurse.
详细描述
Intra-hospital, the prevalence of pain is major; this is variable depending on the studies, but permanently above 60%. A study conducted in 2015 in Tours Adult Emergencies showed a prevalence of pain of 66.5% with an average waiting time of 2h28 before receiving an analgesic.
The pain management protocol at the Tours emergency department includes paracetamol for a numerical evaluation scale (EN) < 3 and tramadol for an EN between 4 and 6. But these therapies have a delay of action too long or are given too late. An improvement in the management of pain in emergency is therefore necessary.
Methoxyflurane (Penthrox®) is a volatile fluoridated analgesic; it offers several benefits: fast over a long period, well tolerated, effective and without interference with other drugs. Despite a misuse in the 70s, it has been used for more than 20 years in Australia and New Zealand. It was granted marketing authorization in 2016 and has been marketed in France since 2017.
It should be noted that this analgesic treatment is already adopted in several hospitals in the region and also in the SAMU 37.
A similar study was conducted in Grenoble but on a different population. The investigators plan to highlight the interest of Penthrox® in the management of monotraumatic pains in the Adult Emergencies of Tours with the intention of modifying the antalgic protocol accordingly to the reception of emergencies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conscious patient
- •Age ≥ 18 years
- •Acute pain of monotraumatic origin
- •Pain > 4 on a visual numerical scale
排除标准
- •State of shock with unstable hemodynamics (PA <90/60)
- •Suspected or proven trauma to the chest, abdomen or pelvis
- •Serious head trauma
- •Consciousness disorder with Glasgow score <15
- •Patient who has already received analgesics (with the exception of paracetamol)
- •Patient receiving an intravenous approach for analgesia
- •Renal or hepatic disorders known
- •Hypersensitivity to fluoridated anesthetics or history of malignant hyperthermia in the patient or family
- •Pregnant or nursing woman
- •Patient under judicial protection
- •Non communicating patient or with difficulties of understanding
- •Exclusion Criteria:
- •Intravenous injection for analgesia
研究组 & 干预措施
Penthrox
Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.
干预措施: Methoxyflurane (Drug)
结局指标
主要结局
Change of traumatic acute pain level between baseline and 15 minutes
时间窗: baseline and 15 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
- Pain extinction duration(baseline and 15, 30, 45, 60 minutes)
- Penthrox tolerance(60 minutes)
- Change of traumatic acute pain level between baseline and 45 minutes(baseline and 45 minutes)
- Medical team level of satisfaction(60 minutes)
- Patient level of satisfaction(60 minutes)
- Change of traumatic acute pain level between baseline and 30 minutes(baseline and 30 minutes)
- Change of traumatic acute pain level between baseline and 60 minutes(baseline and 60 minutes)