Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Phase 4

Completed

• Conditions: Ankle Sprain
• Interventions: Drug: Placebo; Drug: Ketoprofen gel

• Registration Number: NCT02393846
• Lead Sponsor: Akdeniz University

Brief 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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-03
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel.
ketoprofen	Ketoprofen gel	Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	30 minutes	Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	30 minutes	Adverse effects occurred during the study is recorded to the study form.

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey