Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal isonicotinic acid hydrazide on the pain scores during HSG.
详细描述
hysterosalpingography 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 cannula; and injection of the dye
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)
盲法说明
double blind placebo randomized controlled trial
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •any patient came for Hysterosalpingography
排除标准
- •any patient has contraindication to HSG
研究组 & 干预措施
Group B
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table vaginal placebo by the patient 12 hours before the procedure
干预措施: Ketoprofen + placebo (Drug)
Group A
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
干预措施: Ketoprofen + INH (Drug)
结局指标
主要结局
Intensity of pain
时间窗: 15 minutes
pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
次要结局
- Intensity of pain(30 minutes after the procedure)
研究者
hany farouk
A Professor
Aswan University Hospital