NCT01496105Unknown4 期
Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- VAS score of Pain
研究概览
简要总结
The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-45
- •Speak Arabic or English
排除标准
- •History of cervical surgery
- •Known hypersensitivity to topical analgesics
- •First trimester abortion or miscarriage in the previous six weeks
- •Second trimester abortion or miscarriage in the previous 12 weeks
研究组 & 干预措施
lidocaine spray 10%
Active Comparator
干预措施: Lidocaine (Drug)
Saline
Placebo Comparator
干预措施: saline (Drug)
结局指标
主要结局
VAS score of Pain
时间窗: 5 minutes from lidocaine spraying ( after application of tenaculum)
次要结局
未报告次要终点
研究者
Mohamed Saied Eldin Elsafty
Lecturer of Obstetrics and Gynecology
Ain Shams University
研究点 (1)
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