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临床试验/NCT06188143
NCT06188143已完成不适用

The Efficacy of Combination of Ibuprofen and Paracetamol for Pain Control in Diagnostic Hysteroscopy

Phramongkutklao College of Medicine and Hospital2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
The pain score comparing between study and control group

研究概览

简要总结

The goal of this clinical trial study is to learn about how to decrease the pain during the diagnostic hysteroscopy. The main question it aims to answer is "Do the Paracetamol and Ibuprofen taken before the procedure can lower the pain during the diagnostic hysteroscopy".

详细描述

After the participants those are indicated for diagnostic hysteroscopy and eligible for the study undergo informed consent, then they were divided to two groups for control group those get no medication and study group those get Paracetamol 500mg and Ibuprofen40mg per oral before the hysteroscopy, and both group needs to evaluate the pain score in VAS before, during hysteroscopy and after hysteroscopy for 30 minutes to compare the pain level in two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old

排除标准

  • Women with contraindication for undergoing diagnostic hysteroscopy includes women with pregnancy, uterine infection, diagnosed with cervical cancer or endometrium cancer and women who is undergoing with active vaginal bleeding
  • Women with history of allergy to Paracetamol or Ibuprofen medicine
  • Women with currently or pre-existing medical conditions that contraindicate the use of ibuprofen includes kidney disease, heart disease, cirrhosis, gastritis or individuals with a history of peptic ulcer or gastrointestinal bleeding
  • Women with currently taking anticoagulant or antiplatelet medications
  • Women with history of psychiatric disorders

结局指标

主要结局

The pain score comparing between study and control group

时间窗: During and 30minutes after the hysteroscopic procedure

Comparing the pain score in visual analogue scale of 1(minimum) to 10scores(maximum) which is less to more painful respectively(higher score means more painful and worse outcome)

次要结局

  • The associated factors effecting the pain of the procedure(During and 30minutes after the hysteroscopic procedure)

研究者

发起方
Phramongkutklao College of Medicine and Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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