Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mean pain score during. hysterosalpingography by visual analog scale
研究概览
简要总结
Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.
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
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The infertile women who indicated for HSG.
排除标准
- •contraindications to Hyoscine or NSAID - known sensitivity to these drugs
- •known sensitivity to contrast media
- •abnormal uterine bleeding
- •genital tract infection
- •suspected pregnancy
研究组 & 干预措施
Group A
oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure
干预措施: hyoscine butyl bromide (Drug)
Group B
oral 2 tablets (PLACEBO) 30 minutes before the procedure
干预措施: placebo (Drug)
结局指标
主要结局
Mean pain score during. hysterosalpingography by visual analog scale
时间窗: intraoperative
次要结局
- Mean pain score after hysterosalpingography(30 minutes)