Comparative Safety and Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in Relieving Pain During Levonorgestrel IUD Insertion
试验速览
- 阶段
- 4 期
- 入组人数
- 111
- 主要终点
- pain during IUD insertion
研究概览
简要总结
the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in 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
- •nulliparous women requesting levonorgestrel IUD insertion
排除标准
- •multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion
研究组 & 干预措施
lidocaine spray
four puffs (50ml, 10 mg/puff) of lidocaine spray will be applied to the cervical canal and cervix before tenaculum placement plus vaginal placebo will be given 3 hours before IUD insertion
干预措施: lidocaine spray (Drug)
vaginal dinoprostone
vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement
干预措施: vaginal dinoprostone (Drug)
placebo
vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement
干预措施: placebo (Drug)
结局指标
主要结局
pain during IUD insertion
时间窗: 2 minutes
pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable
次要结局
- insertion duration(5 minutes)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University