Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women. A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography
研究概览
简要总结
The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •infertility female
- •no history of HSG or Hysteroscopy
排除标准
- •vaginal or pelvic infection
- •abnormal Pap smear
- •contraindications for Mefenamic acid including upper and lower GI ulcers, bleeding disorder, Asthma or allergies, renal disease, using Warfarin,Aspirin, Lithium, history of Mefenamic acid or Hyoscine allergies
研究组 & 干预措施
Hyoscine, Mefenamic acid, Placebo
Blind randomization to three groups. Mefenamic acid group Hyoscine group Placebo group
干预措施: Mefenamic acid or Hyoscine or placebo (Drug)
结局指标
主要结局
Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography
时间窗: Before, during and after the procedure
次要结局
- Patients satisfaction during saline infusion sonohysterography(After the procedure)