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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02393846

Enrollment

100

Registered

2015-03-20

Start date

2015-02-28

Completion date

2015-06-30

Last updated

2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprain

Keywords

ankle sprain, topical ketoprofen, non-steroidal anti-inflammatory drug, emergency department

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.

Interventions

DRUGKetoprofen gel

Topical ketoprofen as used in gel form.

DRUGPlacebo

Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Adverse effects	30 minutes	Adverse effects occurred during the study is recorded to the study form.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026