Ketoprofen Gel vs Placebo in Children With Ankle Sprain
Information source: Akdeniz University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankle Sprain
Intervention: Ketoprofen (Drug); Placebo (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Akdeniz University Official(s) and/or principal investigator(s): Mustafa Serinken, MD, Study Chair, Affiliation: Pamukkale University
Overall contact: Aysel Özkan, Phone: 00902582961758, Email: karek@pau.edu.tr
Summary
The aim of this study is to analyse the effect of ketoprofen gel in children presented with
ankle sprain to the emergency department.
Clinical Details
Official title: Ketoprofen Gel vs Placebo in Children Presented With Ankle Sprain to the Emergency Department: A Randomised Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Visual Analogue Scale
Secondary outcome: Adverse effects
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.
Eligibility
Minimum age: 8 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Aysel Özkan, Phone: 00902582961758, Email: karek@pau.edu.tr
Pamukkale University, Denizli, Turkey; Recruiting Aysel Özkan, Phone: 00902582961758, Email: karek@pau.edu.tr
Additional Information
Starting date: June 2015
Last updated: July 3, 2015
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