Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device (IUD) Insertion. A Randomized Double Blinded Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.
详细描述
Various studies evaluating the use of local anesthetics or misoprostol prior to IUD insertion have mixed results.We think that the combination of diclofenac and lidocaine gel could be more successful in relieving pain during IUD insertion than single therapy.The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients of reproductive age requesting IUD for contraception
排除标准
- •Patients with contraindications to IUD insertion ( less than 6 weeks postpartum, less than 2 weeks after abortion, uterine anomalies, fibroid distorting uterine cavity, pregnancy, pelvic inflammatory disease, cervicitis, uterine depth less than 6 cm or more than 9 cm) , previous IUD insertion, allergy to diclofenac or lidocaine, peptic ulcer , asthma, bleeding disorders, cardiac, liver or kidney diseases.
研究组 & 干预措施
Diclofenac plus lidocaine
Diclofenac(100 mg) is administered 1 hour before IUD insertion and lidocaine gel is placed on cervix three minutes before IUD insertion
干预措施: Diclofenac plus lidocaine (Drug)
Placebo
Placebo tablets is administered 1 hour before IUD insertion and placebo gel is placed on cervix three minutes before IUD insertion
干预措施: Placebo (Drug)
结局指标
主要结局
Intensity of pain
时间窗: Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 3 minutes]
次要结局
- Adverse effects of diclofenac and lidocaine(Within 24 hours after IUD insertion)