Ketoprofen Gel vs Placebo in Children With Ankle Sprain

Phase 4

• Conditions: Ankle Sprain
• Interventions: Other: Placebo; Drug: Ketoprofen

• Registration Number: NCT02491736
• Lead Sponsor: Akdeniz University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-03
• Study First Posted: 2015-07-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo gel
ketoprofen	Ketoprofen	2.5% ketoprofen gel

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	30 minutes	Measurement of pain reduce at 30 minutes by visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Adverse effects	30 minutes

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey