Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion in Adolescents and Young Women
试验速览
- 阶段
- 3 期
- 入组人数
- 88
- 主要终点
- pain during IUD insertion
研究概览
简要总结
the aim of the study is to evaluate the safety and efficacy of isosorbide mononitrate vaginal administration in reducing pain during LNG-IUD insertion in adolescents and young women
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adolescents and young women requesting LNG-IUD insertion
排除标准
- •heavy vaginal bleeding,pregnancy, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
研究组 & 干预措施
Isosorbide Mononitrate
one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG-IUD insertion
干预措施: Isosorbide Mononitrate 40 MG (Drug)
placebo
one tablet of placebo vaginally 3 hours prior to LNG- IUD insertion
干预措施: Placebo (Drug)
结局指标
主要结局
pain during IUD insertion
时间窗: 5 minutes
intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where 'zero' corresponds to no pain at all, and '10' to the worst possible 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