Effect of Self-administered Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery: A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- The difference in pain scores during intrauterine device insertion
研究概览
简要总结
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .
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 49 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
lidocaine group
lidocaine in-situ gel inserted vaginally
干预措施: lidocaine gel (Drug)
placebo group
placebo gel inserted vaginally
干预措施: placebo gel (Drug)
结局指标
主要结局
The difference in pain scores during intrauterine device insertion
时间窗: 10 minutes
using visual analog scale from 0 to 10
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
principal investigator
Assiut University
