NCT04292808撤回不适用
An Open-Label Study to Assess the Efficacy and Safety of Low Dose Methoxyflurane (PENTHROX®) for Pain Control During Outpatient Aesthetic Surgeries and Facial Filler Injections
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Assessing patient satisfaction
研究概览
简要总结
The aim of the study is to generate real-world evidence on the effectiveness, safety and additional parameters of low dose methoxyflurane (PENTHROX®) in: aesthetic surgeries (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) and facial filler injections [eg. hyaluronic acid (HA) and Sculptra®] in an outpatient aesthetic practice. This will be an open-label study, with a total of 60 patients undergoing a planned outpatient aesthetic surgery or filler injection (30 patients in each group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Conscious adult patients: ≥ 18 years of age
- •Patient is scheduled for an outpatient anesthetic surgery (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) or a facial filler injection (eg. HA, and Sculptra®).
- •Patient 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
- •An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
- •Clinically significant renal impairment
- •Women of child bearing potential who are pregnant or peri partum, including labour
- •A history of liver dysfunction after previous methoxyflurane use or other halogenated anesthetics
- •Hypersensitivity to methoxyflurane 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
- •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
Penthrox
Other
Low Dose Methoxyflurane
干预措施: Methoxyflurane (Drug)
结局指标
主要结局
Assessing patient satisfaction
时间窗: through study completion, an average of 1 year
Global assessment of medication performance (gmp)
次要结局
未报告次要终点
研究者
研究点 (1)
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