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Ketoprofen Gel vs Placebo in Children With Ankle Sprain

Primary Purpose

Ankle Sprain

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ketoprofen
Placebo
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ketoprofen

Placebo

Arm Description

2.5% ketoprofen gel

Placebo gel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse effects

Full Information

First Posted
July 3, 2015
Last Updated
December 2, 2015
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT02491736
Brief Title
Ketoprofen Gel vs Placebo in Children With Ankle Sprain
Official Title
Ketoprofen Gel vs Placebo in Children Presented With Ankle Sprain to the Emergency Department: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akdeniz University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ketoprofen
Arm Type
Experimental
Arm Description
2.5% ketoprofen gel
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo gel
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Other Intervention Name(s)
Fastjel
Intervention Description
2.5% ketoprofen gel
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo gel
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Measurement of pain reduce at 30 minutes by visual analogue scale
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Adverse effects
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysel Özkan
Phone
00902582961758
Email
karek@pau.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Serinken, MD
Organizational Affiliation
Pamukkale University
Official's Role
Study Chair
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aysel Özkan
Phone
00902582961758
Email
karek@pau.edu.tr

12. IPD Sharing Statement

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Ketoprofen Gel vs Placebo in Children With Ankle Sprain

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