The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Topical ketoprofen as used in gel form.
Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.
Pamukkale University
Denizli, Turkey (Türkiye)
Visual analogue scale
Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.
Time frame: 30 minutes
Adverse effects
Adverse effects occurred during the study is recorded to the study form.
Time frame: 30 minutes
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