NCT01094015已完成4 期
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial
Consorci Sanitari de Terrassa1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- pain reduction in the performance of hysteroscopy
研究概览
简要总结
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients that he must perform a diagnostic hysteroscopy
- •acceptance to participate in the study signed informed consent
- •Exclusion Criteria prerandomization:
- •hypersensitivity or allergy to anesthetics
- •refusal of the patient
- •patients under age 18 and pregnant
- •Exclusion Criteria postrandomization:
- •unbearable pain that involves other analgesic measures
- •allergic reactions to topical anesthetics
排除标准
- 未提供
研究组 & 干预措施
Lidocaine-Prilocaine cream
Active Comparator
干预措施: lidocaine-prilocaine cream (Drug)
placebo
Placebo Comparator
干预措施: gel application for the transmission of ultrasound (Other)
结局指标
主要结局
pain reduction in the performance of hysteroscopy
时间窗: after hysteroscopy and a month later
decrease in pain immediately after the completion of hysteroscopy 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 hysteroscopy)
研究者
研究点 (1)
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