EUCTR2017-002352-91-ES进行中（未招募）1 期
Randomised, Double-blind Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo in an outpatient.
Dra Antònia Dalmau i LLitjós del Servicio de Anestesia, Reanimación y Terapéutica del dolor del HUB -Idibell0 个研究点目标入组 46 人开始时间: 2018年2月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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
- •a) signed and dated informed consent before randomization process
- •b) male or female
- •c) older or equal to 18 years
- •d) Patients with painful wound care
- •e) Wounds or ulcers of any origin (vascular deficit, diabetic, traumatic, postsurgical ...) with skin damaged
- •f) Women with a negative result on a pregnancy test.
- •g) Men and women of childbearing potential must agree to use effective contraception throughout treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •a) history of allergic reaction to local anesthetics of the amide type.
- •b) Wounds or ulcers of grade I (injury seamless skin)
- •c) very large wounds (requiring more than 20 ml of solution)
- •d) periocular Wounds
- •e) Patients with impaired cardiac conduction atrioventricular block of 2nd or 3rd degree heart block or bifascicular
- •f) Patients with altered level of consciousness
- •g) Patients on hemodialysis, peritoneal dialysis or continuous hemofiltration
- •h) Patients with moderate or severe hepatic impairment
- •i) Pregnant or breast-feeding.
- •j) Patients who refuse to participate
研究者
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