A Phase IV Real World Study on the Use of Low Dose Methoxyflurane (PENTHROX™) for the Treatment of Moderate to Severe Trauma Pain in the Canadian Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 6
- 主要终点
- Change in mean pain intensity: Numerical Rating Scale
研究概览
简要总结
This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associated with trauma in the Canadian ED.
详细描述
The study will assess the change in pain intensity over 20 minutes from start of administration of PENTHROX™ and will generate Real World Evidence in support of existing clinical trial data including effectiveness, safety and additional parameters of low dose MEOF (PENTHROX™) in Canadian EDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
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
- •Conscious adult patients: ≥ 18 years of age
- •Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as
- •Musculoskeletal injuries and physical wounds
- •Fractures
- •Lacerations
- •Dislocations
- •Contusions
- •Injury due to foreign bodies
- •Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
- •Patient is able to follow all study requirements and procedures and complete required questionnaires
排除标准
- •Multi-level trauma
- •Women of child bearing potential who are pregnant or peri partum, including labour
- •An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
- •Clinically significant renal impairment
- •A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
- •Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
- •Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
- •Exacerbation of an underlying condition (i.e., chronic pain)
- •Clinically evident or potential hemodynamic instability as per the opinion of the investigator
- •Clinically evident respiratory impairment as per the opinion of the investigator
- •Prior treatment with PENTHROX within 3 months
研究组 & 干预措施
Methoxyflurane (MEOF)-active treatment
single arm study all subjects will be treated with Methoxyflurane 3 mL
干预措施: Methoxyflurane 3mL (Drug)
结局指标
主要结局
Change in mean pain intensity: Numerical Rating Scale
时间窗: 20 mins from start of administration (STA) of PENTHROX™
The level of pain intensity will be collected by means of the Numerical Rating Scale (NRS). The NRS is considered a reliable and valid scale for assessing pain intensity and is preferred by patients for its simplicity. In this 11-point scale, the end points are the extremes of no pain and pain as bad as it could be, or worst pain (i.e. a score of 0 = no pain and a score of 10 = worst pain possible). Assessed by the patient 20 mins post PENTHROX™ inhalation
次要结局
- Proportion of treatment-emergent adverse events (TEAEs)(At any point From STA of PENTHROX™ until the end of the observation period (24 hours))
- Speed of action of analgesia(At any point from STA of PENTHROX™ to 20 mins post inhalation)
- Use of rescue medication(From STA of PENTHROX™ to the end of the observation period (up to 24hours))
- Global Medication Performance (GMP) before discharge from ED (Patient & Health Care Professional)(at 20 minutes From STA of PENTHROX™ and at the end of the observation period (up to 24hours))
- Fulfillment of pain relief expectations (Patient & Healthcare professional)(At the end of the observation period (up to 24hours))