NCT02393846

Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Akdeniz University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ankle Sprain

Interventions

Type	Name	Description
DRUG	Ketoprofen gel	Topical ketoprofen as used in gel form.
DRUG	Placebo	Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-03-20
• Last updated: 2015-07-07

Locations

1 site across 1 country: Turkey (Türkiye)