NCT01303614Unknown4 期
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial
Consorci Sanitari de Terrassa1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pain reduction in the performance of hysterosalpingography
研究概览
简要总结
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysterosalpingography diagnostic practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients that must perform a hysterosalpingography
- •acceptance to participate in the study signed informed consent
排除标准
- •hypersensitivity or allergy to anesthetics
- •refusal of the patient
- •patients under age 18 years old and pregnant
- •unbearable pain that involves other analgesic measures
研究组 & 干预措施
Lidocaine-Prilocaine cream
Active Comparator
干预措施: Lidocaine-Prilocaine cream (Drug)
Placebo
Placebo Comparator
purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid
干预措施: placebo (Drug)
结局指标
主要结局
pain reduction in the performance of hysterosalpingography
时间窗: after hysterosalpingography and a month later
decrease in pain inmediately after the completion of hysterosalpingography and one month after completion of the diagnostic test by an analogue pain scale.
次要结局
- sense of discomfort experience during the procedure(a month after hysterosalpingography)
研究者
研究点 (1)
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