Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Akdeniz University

Status and phase: Completed; Phase 4

Conditions: Ankle Sprain

Treatments: Drug: Placebo; Drug: Ketoprofen gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02393846

PAU2015/05

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

ketoprofen

Experimental group

Description:

Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr.

Treatment:

Drug: Ketoprofen gel

Placebo

Placebo Comparator group

Description:

Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel.

Treatment:

Drug: Placebo