Ketoprofen Gel vs Placebo in Children With Ankle Sprain

Ankle Sprain Clinical Trial

Official title:

Ketoprofen Gel vs Placebo in Children Presented With Ankle Sprain to the Emergency Department: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02491736
• Other study ID #: 16445
• Status: Recruiting
• Phase: Phase 4
• First received: July 3, 2015
• Last updated: December 2, 2015
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: Akdeniz University
• Contact: Aysel Özkan
• Phone: 00902582961758
• Email: karek[@]pau.edu.tr
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Drug:
• Ketoprofen
2.5% ketoprofen gel

Other:
• Placebo
Placebo gel

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	Measurement of pain reduce at 30 minutes by visual analogue scale	30 minutes	No
Secondary	Adverse effects		30 minutes	Yes