Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in Reducing Pain During IUD Insertion in Adolescents and Nulliparous Women: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- pain during IUD insertion
研究概览
简要总结
the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •adolescent and young nulliparous women requesting IUD insertion
排除标准
- •multiparous women, contraindications to IUD insertion or to study drugs
研究组 & 干预措施
lidocaine spray
four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
干预措施: lidocaine spray (Drug)
vaginal misoprostol
vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
干预措施: vaginal misoprostol (Drug)
placebo
vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
干预措施: placebo (Drug)
结局指标
主要结局
pain during IUD insertion
时间窗: 5 minutes
pain during IUD insertion evaluated by visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable
次要结局
- duration of IUD insertion(5 minutes)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University