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Ketoprofen Gel vs Placebo in Children With Ankle Sprain

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ClinicalTrials.gov Identifier: NCT02491736
Recruitment Status : Unknown
Verified December 2015 by Akdeniz University.
Recruitment status was:  Recruiting
First Posted : July 8, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ankle Sprain Drug: Ketoprofen Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketoprofen Gel vs Placebo in Children Presented With Ankle Sprain to the Emergency Department: A Randomised Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketoprofen

Arm Intervention/treatment
Experimental: ketoprofen
2.5% ketoprofen gel
Drug: Ketoprofen
2.5% ketoprofen gel
Other Name: Fastjel

Placebo Comparator: Placebo
Placebo gel
Other: Placebo
Placebo gel




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 30 minutes ]
    Measurement of pain reduce at 30 minutes by visual analogue scale


Secondary Outcome Measures :
  1. Adverse effects [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491736


Contacts
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Contact: Aysel Özkan 00902582961758 karek@pau.edu.tr

Locations
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Turkey
Pamukkale University Recruiting
Denizli, Turkey
Contact: Aysel Özkan    00902582961758    karek@pau.edu.tr   
Sponsors and Collaborators
Akdeniz University
Investigators
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Study Chair: Mustafa Serinken, MD Pamukkale University

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Responsible Party: Akdeniz University
ClinicalTrials.gov Identifier: NCT02491736     History of Changes
Other Study ID Numbers: 16445
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action