Effect of Oral Ketoprofen on Intra Uterine Device Insertion Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean pain score during IUD insertion
研究概览
简要总结
IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.
详细描述
To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women not taken analgesics or anxiolytics in the 24 hours prior insertion
- •Women not taken misoprostol prior to insertion
- •No contraindication to Non-steroidal drugs
- •Women who will accept to participate in the study
排除标准
- •Any contraindication to device placement
研究组 & 干预措施
Ketoprofen
women will take one tablet 150 mg one hour before the procedure
干预措施: Ketoprofen (Drug)
Placebo
women will take one placebo tablet one hour before the procedure
干预措施: placebo (Drug)
结局指标
主要结局
Mean pain score during IUD insertion
时间窗: 5 minutes
次要结局
未报告次要终点