EUCTR2018-001601-82-NL进行中（未招募）1 期
Open randomized clinical trial to compare pain relief between low-dose methoxyflurane and standard of care for the treatment of patients with trauma pain in emergency medical services in the Netherlands. - Low-dose MEOF vs SoC for trauma pain in emergency medical services
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients should be = 18 years of age
- •-Moderate pain (NRS0-10 =4 and =8) secondary to extremity injuries
- •-Conscious patients with a stable circulation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Hypersensitivity to 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 (excluding oral WHO-step 1 analgesics) for the trauma pain before inclusion
- •-Altered level of consciousness due to any cause, including head injury, drugs or alcohol
- •- Active alcohol or drug abuse and/or history of opioid abuse
- •-Degenerative diseases, mental illness or other conditions that could affect ability of valuing pain intensity
- •-Patients 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.
研究者
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