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Ketoprofen Gel vs Placebo in Children With Ankle Sprain

NCT ID: NCT02491736

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketoprofen

2.5% ketoprofen gel

Group Type EXPERIMENTAL

Ketoprofen

Intervention Type DRUG

2.5% ketoprofen gel

Placebo

Placebo gel

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo gel

Interventions

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Ketoprofen

2.5% ketoprofen gel

Intervention Type DRUG

Placebo

Placebo gel

Intervention Type OTHER

Other Intervention Names

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Fastjel

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mustafa Serinken, MD

Role: STUDY_CHAIR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Aysel Özkan

Role: CONTACT

[email protected]
00902582961758

Facility Contacts

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Aysel Özkan

Role: primary

[email protected]
00902582961758

Other Identifiers

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16445

Identifier Type: -

Identifier Source: org_study_id