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临床试验/NCT02491879
NCT02491879Unknown4 期

Ketoprofen Gel vs Placebo in Patients Presented With Low-back Pain to Emergency Department: A Ranodmized Controlled Trial

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6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

This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

详细描述

Mechanical low-back pain which warrants immediate pain relief is not an infrequent symptom for emergency department physicians to deal with. Parenteral analgesic is the most common drugs for the these patients in emergency department. However, pain killers in gel forms have not been studied sufficiently for ceasing the pain of these patients. This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 and lower 65 years old
  • Patients presented with mechanical low-back pain

排除标准

  • Pain more than 24 hours
  • Pain lower than with a pain score of 40 mm
  • Allergy to ketoprofen
  • Drug or alcohol addiction
  • pregnancy and breast feeding

研究组 & 干预措施

Ketoprofen

Experimental

Ketoprofen gel

干预措施: Ketoprofen (Drug)

Placebo

Placebo Comparator

Placebo form of ketoprofen gel

干预措施: Placebo (Other)

结局指标

主要结局

Visual Analogue Scale

时间窗: 30 minutes

Pain reduce will be measured by visual analogue scale score at 30 minutes

次要结局

  • Adverse outcome(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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