Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ankle Sprain

Intervention / Treatment
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* Drug: Ketoprofen gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presented with ankle sprain to the emergency department. Patients between 18-65 years old. Exclusion Criteria: Pain over 24 hours, Pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse pregnancy or breastfeeding are the exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketoprofen<br>Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr. | Drug: Ketoprofen gel<br>* Topical ketoprofen as used in gel form.<br>* Other names: Fastjel;|
| Placebo Comparator: Placebo<br>Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel. | Drug: Placebo<br>* Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.<br>* Other names: Placebo gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Adverse effects occurred during the study is recorded to the study form. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle sprain, topical ketoprofen, non-steroidal anti-inflammatory drug, emergency department