EUCTR2017-001565-25-IT进行中（未招募）1 期
Efficacy and safety of methoxyflurane vaporized (PENTHROX®) in the treatment of acute trauma pain in pre-hospital setting and in the emergency department in Italy: a multicentre, randomized, controlled, open-label study - MEDITA
MUNDIPHARMA PHARMACEUTICALS SR0 个研究点目标入组 272 人开始时间: 2018年3月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 272
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
- •Written informed consent must be provided by each patient prior to any study-specific activity. In cases where the patient is unable to write autonomously, it must be obtained a verbal consent in presence of a witness that the patient will have to confirm autonomously as soon as (s)he is able
- •Stable, vigilant and collaborative patient i.e. able to understand and communicate with the examiner in order to carry out the study activities
- •Age = 18 years
- •Trauma to the limbs (fracture, dislocation, crushing, bruising) in a single district.
- •N.B. For recruiting, given the particular setting, no instrumental confirmation is required but suspicion of involvement of a single district is sufficient.
- •Moderate to severe pain, detected by the Numerical Rating Scale (NRS score =4)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •Personal or family history (parents or siblings) for malignant hyperthermia.
- •History of severe adverse reactions to inhaled anesthetics.
- •History of renal failure
- •history of liver failure.
- •trauma risky dynamics (ejection from the vehicle, cabin deformation, death of an occupant of the same vehicle, motor vehicle / pedestrian or cyclist impact with a motor vehicle in motion, projection / overturn, fall from a height of> 3 meters, extraction on event place > 20 min).
- •Altered level of vigilance and / or conscience (GCS <15)
- •Symptomatic hypotension or Systolic Pressure <100 mm / Hg
- •Discomfort with FR> 20 and SatO2 in air <95%
- •Known pregnancy status.Note: a 1 day delay with respect to the planned menstruation date (28days since the beginning of the previous one) has to be considered a suspected pregnancy.
- •Hypersensitivity to methoxyflurane, to any fluorinated anesthetic or to the E321 butylhydroxytoluene excipient.
- •Current treatment with any analgesic for chronic pain or in the previous 5 hours (8 hours in the case of diclofenac).
- •Known allergy to both paracetamol and non-steroidal anti-inflammatory drugs or known hypersensitivity to morphine
- •All types of acute abdomen and paralytic ileus
- •Hearth failure
- •Recent (within2 months) biliary tract surgery
- •Current bronchial asthma attack
- •Uncontrolled epilepsy
- •Depressive state treated with IMAO (ongoing or interrupted less 3 wks ago)
- •Theatment with naltrexone
- •History of active or recurrent peptic ulcer/hemorrhage (2 or more episodes of documented ulceration or bleeing in the last 6 months)
- •Bleeding diathesis
- •Current Intensive diuretic therapy
- •Chronic dyspepsia, gastritis with significant episodes in the last 2 months
- •Leucopenia and thrombocytopenia, current hemorrhages
- •Current anticoagulant therapy
研究者
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