临床试验/NCT02491736

NCT02491736Unknown4 期

Ketoprofen Gel vs Placebo in Children Presented With Ankle Sprain to the Emergency Department: A Randomised 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: 2015年12月3日

适应症

干预措施

试验速览

阶段: 4 期
发起方: Akdeniz University
入组人数: 100
试验地点: 1
主要终点: Visual Analogue Scale

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 this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain to the emergency department.

详细描述

Ankle sprains may be associated with soft tissue injuries and fractures. Although diagnostic modalities are important, alleviation of pain is also a part of emergency department management. The aim of this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain 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: 8 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with ankle sprain
•Patients over 8 and lower than 18 years old

排除标准

•Ankle sprain more than 24 hours
•visual analogue scale score lower than 40mm
•Allergy to the study drug

研究组 & 干预措施

ketoprofen

Experimental

2.5% ketoprofen gel

干预措施: Ketoprofen (Drug)

Placebo

Placebo Comparator

Placebo gel

干预措施: Placebo (Other)

结局指标

主要结局

Visual Analogue Scale

时间窗: 30 minutes

Measurement of pain reduce at 30 minutes by visual analogue scale

次要结局

Adverse effects(30 minutes)

研究者

发起方

Akdeniz University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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终止

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