临床试验/NCT02943135

NCT02943135已完成3 期

Effect of Self-administered Lidocaine In-situ Gel on Intrauterine Device Insertion Pain: A Randomized Controlled Trial

Assiut University2 个研究点分布在 1 个国家目标入组 120 人开始时间: 2017年10月1日最近更新: 2020年5月20日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Assiut University
入组人数: 120
试验地点: 2
主要终点: Mean pain score during intrauterine device insertion

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Intrauterine device 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 insertion tube, and removing the tube; and placement of the device in the uterus.

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: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 20 Years 至 50 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Women not taken analgesics or anxiolytics in the 24 hours prior insertion
•Women not taken misoprostol prior to insertion
•No contraindication to or history of allergic reaction to lidocaine
•Women who will accept to participate in the study

排除标准

•Lidocaine allergy
•Any contraindication to device placement

研究组 & 干预措施

lidocaine in-situ

Active Comparator

Self-administered gel 10 min before intrauterine device insertion

干预措施: lidocaine in-situ gel (Drug)

placebo

Placebo Comparator

Self-administered gel 10 min before intrauterine device insertion

干预措施: placebo in-situ gel (Drug)

结局指标

主要结局

Mean pain score during intrauterine device insertion

时间窗: 30 min

次要结局

未报告次要终点

研究者

发起方

Assiut University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ahmed Mohamed Abbas

Assiut University

研究点 (2)

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