Effect of Topical Xylocaine for Pain Relief During Hysterosalpingography Among Infertile Women in Zaria, Nigeria: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain perception
研究概览
简要总结
The study will involve giving topical analgesia or placebo and then assessing pain and satisfaction during and after the procedure in order to see wed to the placebo.hether the topical analgesia has helped in decreasing pain associated with the procedure and also whether it has increasedd satisfaction with the procedure compar
详细描述
STUDY DESIGN:
The study will be a double blind randomized controlled trial. Group A:The study group will be given topical Xylocaine (2% Lidocaine) before the procedure.
Group B:The control group will be given topical K-Y jelly (water based lubricant) before the procedure.
The participants and the radiologist will be blinded at the point of drug administration.
SAMPLE SIZE DETERMINATION:
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
- Single (Care Provider)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women that are sent in to the department of radiology for Hysterosalpingogram as part of evaluation for infertility that give consent.
排除标准
- •Women that present for hysterosalpingography for other indications apart from infertility and those that have history of allergy to xylocaine and/or K-Y jelly.
研究组 & 干预措施
Control group
15g of KY Jelly
干预措施: KY jelly (Drug)
Study Group
15g of Topical Xylocaine gel
干预措施: Lidocaine Gel (Drug)
结局指标
主要结局
Pain perception
时间窗: witthin 45 minutes of the procedure
The pain score based on visual pain scale that assesses pain perception. It is a scale of 0 to 10. 0 = absence of pain. 1. = discomfort 2. = mild pain. 3. = annoying pain. 4. = nagging pain. 5. = distressing pain. 6. = miserable. 7. = intense 8. = Dreadful. 9. = worse possible 10. = unbearable
次要结局
- Patients Satisfaction with procedure(witthin 45 minutes of the procedure)
研究者
Anisah Yahya
Doctor
Ahmadu Bello University Teaching Hospital