Methoxyflurane versus Standard Care for Non-Traumatic Pain in the Emergency Department (PAIN-THROX) : A Multicenter, Randomized, Controlled, Superiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 3
- 主要终点
- The primary endpoint will be pain assessed using the Visual Analog Scale (VAS). The VAS is a simple pain assessment tool consisting of marking a point on a color-graded ruler calibrated in millimeters, allowing pain intensity to be assigned a numerical value ranging from 0 (no pain) to 100 mm (unbearable pain). Pain will be assessed at inclusion, at 3 minutes post-randomization, and then at 5, 10, 15, 20, 25, and 30 minutes using self-administered questionnaires.
研究概览
简要总结
The primary objective is to demonstrate the superiority of methoxyflurane in achieving rapid effective analgesia compared with standard pain management based on oral analgesics, in the emergency department waiting room, in adult patients presenting with non-traumatic painful conditions.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 years
- •Moderate to severe acute non-traumatic pain (VAS strictly greater than 39 mm)
- •Able to self-assess pain using a VAS and to independently record this on a paper form
- •Affiliated with a social security system
- •Has provided written informed consent
排除标准
- •Age < 18 years
- •Patients currently within the exclusion period of another clinical trial.
- •Contraindications to methoxyflurane as described in the Summary of Product Characteristics (SmPC): o Hypersensitivity to the active substance, to any fluorinated anesthetic, or to any excipient listed in section 6.1 of the SmPC o Malignant hyperthermia: known history or genetic predisposition o History of serious adverse reactions (in the patient or relatives) following administration of inhaled anesthetics o History of signs of liver injury following methoxyflurane use or anesthesia with halogenated hydrocarbons o Clinically significant renal impairment o Altered level of consciousness from any cause, including head injury, drug or alcohol use o Clinical evidence of cardiovascular instability o Clinical evidence of respiratory depression
- •Hemodynamically unstable patient (SBP < 100 mmHg, DBP < 30 mmHg)
- •Patient who has already received methoxyflurane on the same day
- •Patient who has taken analgesic treatment prior to emergency department consultation within 4 hours of admission.
- •Pain ≤ 39 mm
- •Pregnant or breastfeeding women
- •Individuals under legal protection (guardianship, curatorship, or judicial protection)
- •Women of childbearing potential not using a highly effective method of contraception throughout the study
结局指标
主要结局
The primary endpoint will be pain assessed using the Visual Analog Scale (VAS). The VAS is a simple pain assessment tool consisting of marking a point on a color-graded ruler calibrated in millimeters, allowing pain intensity to be assigned a numerical value ranging from 0 (no pain) to 100 mm (unbearable pain). Pain will be assessed at inclusion, at 3 minutes post-randomization, and then at 5, 10, 15, 20, 25, and 30 minutes using self-administered questionnaires.
The primary endpoint will be pain assessed using the Visual Analog Scale (VAS). The VAS is a simple pain assessment tool consisting of marking a point on a color-graded ruler calibrated in millimeters, allowing pain intensity to be assigned a numerical value ranging from 0 (no pain) to 100 mm (unbearable pain). Pain will be assessed at inclusion, at 3 minutes post-randomization, and then at 5, 10, 15, 20, 25, and 30 minutes using self-administered questionnaires.
次要结局
- Time to onset of pain relief within the first 30 minutes.Measurement of VAS over the first 30 minutes
- Pain measured again using the VAS at 60, 90, and 120 minutes post-randomization via self-administered questionnaires.
- The need for rescue analgesic treatment of any class due to insufficient pain relief or pain recurrence.
- Adverse events and serious adverse events reported in each group.
研究者
Mickael SOLETCHNIK
Scientific
Centre Hospitalier Regional Universitaire De Tours