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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

Page last updated: August 23, 2015

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