临床试验/NCT04312061

NCT04312061Unknown3 期

Safety and Efficacy of Oral Tramadol Administration in Reducing Pain During Levonorgestrel Intrauterine Device Insertion in Adolescents and Young Women: a Randomized Controlled Trial

Cairo University0 个研究点目标入组 108 人开始时间: 2020年3月30日最近更新: 2020年3月18日

适应症

干预措施

试验速览

阶段: 3 期
发起方: Cairo University
入组人数: 108
主要终点: pain during IUD 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记录与标识符相似试验

研究概览

简要总结

the aim of the study is to evaluate the safety and efficacy of oral tramadol administration in reducing pain during LNG- IUD insertion in adolescents and young women

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: 14 Years 至 25 Years（Child, Adult）
性别: Female
接受健康志愿者: 否

入选标准

•nulliparous adolescents and young women requesting LNG-IUD insertion

排除标准

•parous women, contraindications to LNG-IUD insertion and allergy or contraindications to tramadol

研究组 & 干预措施

oral tramadol

Experimental

oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion

干预措施: oral tramadol (Drug)

placebo

Placebo Comparator

oral placebo tablet given 1 hour before LNG-IUD insertion

干预措施: Placebo oral tablet (Drug)

结局指标

主要结局

pain during IUD insertion

时间窗: 5 minutes

intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where 'zero' corresponds to no pain at all, and '10' to the worst possible pain imaginable.

次要结局

duration of the procedure(5 minutes)

研究者

发起方

Cairo University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ahmed Samy aly ashour

assistant professor obstetrics and gynecology

Cairo University

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