NCT02020551已完成不适用
Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion
Kayseri Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age >18 Not pregnant Smear negative
排除标准
- •Chronic pelvic pain Pregnancy Uterine anomaly Fibroid Acute cervicitis Pelvic inflammatory disease Cervical stenosis
研究组 & 干预措施
saline spray application
Placebo Comparator
Placebo group
干预措施: Placebo (Drug)
lidocaine spray application
Experimental
2 puff lidocaine spray applicated before IUD insertion
干预措施: Lidocaine Spray (Drug)
结局指标
主要结局
Pain
时间窗: 3 months
10 cm VAS scale
次要结局
未报告次要终点
研究者
Gökhan Açmaz
MD
Kayseri Education and Research Hospital
研究点 (1)
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