EUCTR2016-004290-41-GB进行中（未招募）1 期
A randomised, double-blind, multicentre, placebo controlled study to evaluate the safety and efficacy of methoxyflurane (PENTHROX®) for the treatment of acute pain in children and adolescents from 6 to less than 18 years of age (presenting to an Emergency Department with minor trauma) - MAGPIE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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
- •1.Patients aged 6 to less than 18 years.
- •2.Attending ED following minor trauma.
- •3.Evidence of signed and dated informed consent/assent document indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study.
- •4.Pain scores 60 to 80 mm as measured using VAS or 6 to 8 using Wong Baker FACES® Pain Rating scale.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 222
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Critical, life- or limb-threatening condition requiring immediate management.
- •2.Open fractures.
- •3.Patients with any other clinical condition that may, in the opinion of the Investigator, impact the patient’s ability to participate in the study, or the study results.
- •4.Patients deemed not cognitively capable of effectively self-administering the study drug using the PENTHROX® inhaler.
- •5. Treatment with any analgesic agent within 5 hours prior to presentation to ED, except Entonox (50% nitrous oxide and 50% oxygen mixture) which is prohibited within 30 minutes prior to arrival at ED, diclofenac which is prohibited within 8 hours prior to presentation to ED or oral morphine which is prohibited within 10 hours prior to presentation to ED.
- •6.Patients with chronic pain.
- •7.Patients having received an IMP in the preceding 3 months.
- •8.Known pregnancy or breastfeeding females.
- •9.Personal or familial hypersensitivity to PENTHROX® or any fluorinated anaesthetics.
- •10.Patients requiring oxygen therapy.
- •11.Patients with known or genetic susceptibility to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
- •12.Clinically evident respiratory depression.
- •13.Previous use of methoxyflurane (including as an IMP).
- •14.History of signs of liver damage including after previous PENTHROX® (methoxyflurane) use or halogenated hydrocarbon anaesthesia.
- •15.Known significant renal impairment.
- •16.Altered level of consciousness due to any cause including head injury, drugs, or alcohol.
- •17.Known significant cardiovascular disease (e.g., pathological arrhythmia).
- •18.Inability to participate in telephonic follow-up on (Day 14 ± 2 days) as per study requirement.
研究者
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