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临床试验/NCT02373514
NCT02373514Unknown4 期

Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department

Akdeniz University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

Patients presented with dysmenorrhea composed the study population. One gram paracetamol and 50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing dysmenorrhea in emergency department.

详细描述

Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received pain killer within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients are measured with visual analogue scale at baseline, 15th and 30th minutes. At the end of the 30 minutes, rescue drug need is also recorded.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients with dysmenorrhea
  • Patients over 18 years old

排除标准

  • denied to give inform consent
  • Renal or liver failure
  • Allergy to the study drugs
  • Receiving pain killer within the last 6 hours.
  • Physical examination findings consistent with peritoneal irritation
  • Pregnancy or patients with lactation
  • Drug addiction

研究组 & 干预措施

Paracetamol

Active Comparator

Intravenous 1 gm paracetamol in 100 ml saline with rapid infusion

干预措施: Paracetamol (Drug)

Dexketoprofen

Active Comparator

Intravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion

干预措施: Dexketoprofen (Drug)

结局指标

主要结局

Visual Analogue Scale

时间窗: 30 minutes

Change in visual analogue scale at 30th minutes from baseline

次要结局

  • Rescue drug need(30 minutes)
  • Adverse effects(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cenker Eken

Associate Professor

Akdeniz University

研究点 (1)

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