NCT01420159已完成3 期
A Randomised, Double Blind, Multi-centre, Placebo Controlled Study to Evaluate the Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Patients Presenting to an Emergency Department With Minor Trauma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- VAS Score
研究概览
简要总结
This study investigates the treatment of acute pain, an unpleasant feeling caused by an injury. The overall purpose of the study is to gain more information that the pain relief medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive green, whistle like object that you breathe through) is safe and works at relieving pain in patients aged 12 years and older who are admitted to a hospital Emergency Department with a minor injury (known as trauma).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 12 years of age or older who are able to give written informed consent or who are accompanied by a parent(s)/legal guardian able to provide written informed consent on their behalf.
- •Evidence of signed and dated informed consent document(s) indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study.
- •Pain Score ≥ 4 to ≤ 7 as measured using Numerical Rating Scale (NRS) at the time of admission, due to minor trauma.
排除标准
- •Life-threatening condition requiring immediate admission in the Operating Room or Intensive Care Unit.
- •Presence of any other clinical condition(s) that may, in the opinion of the investigator, impact on the patient's ability to participate in the study, or on the study results, including history of head injury and/or altered consciousness.
- •Unable to provide written informed consent.
- •Known pregnancy or lactation
- •Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
- •Treatment with any analgesic agent within 5 hours prior to presentation to ED (except diclofenac sodium which is prohibited within 8 hours prior to presentation to ED).
- •Current ongoing use of analgesics for chronic pain.
- •Use of an investigational product within one month prior to presentation to ED.
- •Known personal or familial hypersensitivity to fluorinated anaesthetics.
- •Known personal or familial history of malignant hyperthermia.
- •Clinically significant respiratory depression.
- •Use of methoxyflurane in the previous 4 weeks.
- •Known pre-existing clinically significant renal or hepatic impairment according to the judgement of the clinician.
- •Clinically significant cardiovascular instability.
研究组 & 干预措施
Methoxyflurane
Experimental
干预措施: Methoxyflurane (Drug)
Normal Saline
Placebo Comparator
干预措施: Methoxyflurane (Drug)
结局指标
主要结局
VAS Score
时间窗: Twenty Minutes
The difference between treatment and placebo on the VAS pain score
次要结局
- Time to pain relief(Up to a maximum of 6 hours)
- Rescue Medication(Up to a maximum of 6 hours)
- Responder analysis(Up to a maximum of 6 hours)
- Safety Analysis(Up to 16 days)
研究者
研究点 (6)
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