Ketoprofen Gel vs Placebo in Children With Ankle Sprain

December 2, 2015 updated by: Akdeniz University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey
        • Recruiting
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo gel
Other: Placebo
Placebo gel
Experimental: ketoprofen
2.5% ketoprofen gel
Drug: Ketoprofen
2.5% ketoprofen gel
Other Names:
  • Fastjel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 30 minutes
Measurement of pain reduce at 30 minutes by visual analogue scale
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse effects
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

July 3, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16445

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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