NL-OMON50181已完成3 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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mundipharma
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients should be * 18 years of age and competent to participate in the
- •study according to the Investigator*s opinion.
- •2. Moderate pain (NRS0-10 *4 and *8) secondary to extremity injuries
- •3. Conscious patients with a stable circulation
排除标准
- •A potential subject who meets any of the defined criteria will not be eligible
- •for participation in this study and will be treated according to SoC. These
- •criteria will be judged by the Investigator prior to study participation and
- •will be based on (hetero)anamnesis. The defined criteria are:
- •1. Known hypersensitivity to MEOF or any fluorinated anaesthetic.
- •2. Personal or family history of malignant hyperthermia.
- •3. Patients with known liver disease and patients who have a history of showing
- •signs of liver damage after previous MEOF use or halogenated hydrocarbon
- •anaesthesia
- •4. Known clinically significant renal impairment
- •5. Known pregnant or likely to be pregnant women at the time of inclusion.
- •6. Clinically evident cardiovascular instability
- •7. Clinically evident respiratory depression
- •8. Treatment with analgesia (with the exception of oral WHO-step 1 analgesics)
- •prior to arrival of the EMS to reduce pain caused by the trauma.
- •9. Altered level of consciousness due to any cause, including head injury,
- •drugs or al-cohol
- •10. Active alcohol or drug abuse and/or history of opioid abuse
- •11. Degenerative diseases, mental illness or other conditions that could affect
- •ability of valuing pain intensity
- •12. Patients unable to understand the purpose of the study and perform
- •self-assessments, following investigator*s criteria.
- •13. Participation in another clinical trial within 30 days prior to
- •randomization.
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