Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Status Completed

Clinical Trial Summary

The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.

Clinical Trial Description

Patients, 18-65 years old, presented with ankle sprain are enrolled into the study. Pain over 24 hours, pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse and pregnancy or breastfeeding are the exclusion criteria. The study interventions are 2 gr of 2.5% ketoprofen gel versus placebo applied to the sprain area. The study drugs are identical in colour, form and smelling. After an eligible patient presented to the ED, the drug number from an opaque bag is determined by a nurse and then another nurse applies the study drug to the patient. Physicians, nurses and patients are blinded to the study drug. Pain intensity of patients is measured by visual analogue scale at baseline, 15th and 30th minutes after the administration. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02393846
Study type	Interventional
Source	Akdeniz University
Contact
Status	Completed
Phase	Phase 4
Start date	February 2015
Completion date	June 2015

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