NCT00562211已完成1 期
A Single-blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in Children.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Self report assessment of pain (using the Visual Analog Scale)
研究概览
简要总结
A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been developed and is tested in this study (LidoDyn).
The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic agent (EMLA crème).
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously healthy children of whom venipuncture is needed to be performed.
排除标准
- •History of allergic reaction to any local anesthetic.
- •History of chronic disease
- •Patient's condition requires urgent treatment (e.g. severe dehydration, shock)
- •Active local skin infection or skin pathologic condition at the antecubital fossa
- •Tattoo, surgical scar or skin condition that might interfere with skin sight assessment.
- •Patient undergone venipuncture at the antecubital fossa within the pror two weeks.
- •Uncooperative or exceptionally anxious patient.
研究组 & 干预措施
1
Experimental
干预措施: LidoDyn (Drug)
2
Active Comparator
干预措施: EMLA creme (Drug)
结局指标
主要结局
Self report assessment of pain (using the Visual Analog Scale)
时间窗: 60 Min+ 5-10 Min
次要结局
- Medical staff observational assessment of pain (in a scale of 0 to 10)(60 Min + 5-10 Min)
研究者
i_shavit
Pediatric Emergency Department director
Rambam Health Care Campus
研究点 (1)
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