Open Randomized Clinical Trial to Compare Pain Relief Between Methoxyflurane and Standard of Care for Treating Patients With Trauma Pain in Spanish Emergency Units.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 14
- 主要终点
- Pain relief
研究概览
简要总结
Clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used in usual clinical practice, in patients with trauma and associated pain, treated in Spanish emergency units.
详细描述
Open, randomized clinical trial to compare emergency pain relief between methoxyflurane and standard of care in patients with trauma and associated pain, treated in Spanish emergency units.
Methoxyflurane is a fluorinated ethyl methyl ether, with the chemical name 2:2-dichloro-1:1-difluoroethyl methyl ether. It belongs to the fluorinated hydrocarbon group of volatile anaesthetics. It is inhaled as a vapour at low (sub-anaesthetic) concentrations to achieve an analgesic effect for the management of pain.
In Europe countries, where methoxyflurane is already marketed, it is indicated for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.
On the other hand, current clinical practice includes a variety of analgesic agents, with the choice of which to employ based on consideration of the risk-benefit factors of each class of drug, as well as the type of pain, its severity, and the risk of adverse effects.
The main objective of this study is to assess Methoxyflurane's significant advantage in terms of anaglesic effectiveness, as it is known as a rapidly acting, non-narcotic analgesic for the treatment of emergency pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients: ≥ 18 years of age
- •Moderate to severe pain (NRS 0-10; >=4) secondary to trauma
- •Without anticipating surgery due to the trauma, requiring hospitalization (hospital stay 12h)
- •Conscious patient.
- •Giving informed consent in writing
排除标准
- •Hypersensitivity to methoxyflurane (MEOF) or any fluorinated anaesthetic.
- •Malignant hyperthermia: patients with known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
- •Patients who have a history of showing signs of liver damage after previous MEOF use or halogenated hydrocarbon anaesthesia
- •Known clinically significant renal impairment
- •Known pregnant or likely to be pregnant women at the time of inclusion.
- •Clinically evident cardiovascular instability
- •Clinically evident respiratory depression
- •Patients taken any analgesic for the traumatic pain before inclusion
- •Altered level of consciousness due to any cause, including head injury, drugs or alcohol
- •Degenerative diseases, mental illness or other conditions that could affect ability of valuing pain intensity
- •Patients to be unable to understand the purpose of the study and perform self-assessments, following investigator's criteria.
- •Participation in another clinical trial within 30 days prior to randomization
研究组 & 干预措施
Methoxyflurane
Patients will be supplied with up to two inhalers containing 3 mL methoxyflurane. A member of the research team will train the patient to self-administer methoxyflurane
干预措施: Methoxyflurane (Drug)
Standard of Care (SoC)
Patients will be treated following standard of care (SoC) of the hospital, for emergency relief of trauma and associated pain. Any kind of analgesia administered by any route will be valid. Only administration of one analgesic (or fixed combinations) at baseline will considered SoC. Other required analgesics will be considered rescue medication.
干预措施: Standard of care (Drug)
结局指标
主要结局
Pain relief
时间窗: At baseline, 3, 5, 10, 15 and 20 minutes from STA
Change in mean pain intensity over 20 min from start of administration (STA) and time to first pain relief, measured by numeric scale (0-10)
Analgesia effectiveness
时间窗: Change from baseline to 3, 5, 10, 15, 20 and 30 min
Difference between arms related to analgesia effectiveness
Analgesia speed of action
时间窗: From time of randomization up to 20 minutes
Difference between arms related to speed of action of analgesia for all patients
Patient-averaged summed pain intensity difference 15 min after STA
时间窗: from baseline to 3, 5, 10 and 15 minutes post dose
Patient-averaged summed pain intensity difference 15 min after STA
Pain Responders
时间窗: from baseline to 20 minutes post dose
Pain Responders (with \>30% pain relief compared to baseline) at 20 min
Safety for patients with severe pain, treated with second or third step analgesics
时间窗: Up until 14 days from STA
Difference between arms related to safety for patients with severe pain (NRS \>7), treated with second or third step analgesics
次要结局
- Patient and investigators' fulfillment of expectations(30 min from start of administration)
- Patients' Global Impression of Change with the treatments(Up until 30 minutes from STA)
- Investigators and patients satisfaction(30 min from start of administration)
- Treatment cost of pain relief(Up until 60 minutes from randomization)
- Safety rates of treatment emergent adverse events(Up until 14 days from STA)
研究者
Alberto M. Borobia
MD, PhD
Hospital Universitario La Paz