临床试验/NCT02714231

NCT02714231已完成4 期

A Randomized Controlled Trial of 2 Different Methods for Pain Relief During Intrauterine Device Insertion

Assiut University1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新: 2017年7月19日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Assiut University
入组人数: 100
试验地点: 1
主要终点: Mean pain score during 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

The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion.

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: Single (Participant)

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 intrauterine device insertion
•Women who will accept to participate in the study

排除标准

•Any contraindication to intrauterine device placement

研究组 & 干预措施

diclofenac

Experimental

oral diclofuhenac sodium

干预措施: diclofenac sodium (cataflam) (Drug)

hyoscine

Active Comparator

oral hyoscine butyl bromide

干预措施: hyoscine butyl bromide (buscopan) (Drug)

结局指标

主要结局

Mean pain score during insertion

时间窗: intraoperative

次要结局

Patient satisfaction score(5 minutes)

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 (1)

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