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Completed

NCT Number: NCT02393846

Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

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

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Key information

Conditions

Ankle Sprain Ankle Injuries Disease Attributes Emergencies Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketoprofen gel

Drug

Topical ketoprofen as used in gel form.

Other names: Fastjel

Placebo

Drug

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

Other names: Placebo gel

Primary outcomes

  1. Visual analogue scale

    Time frame: 30 minutes

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

Secondary outcomes

  1. Adverse effects

    Time frame: 30 minutes

    Adverse effects occurred during the study is recorded to the study form.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Collaborators

  • Pamukkale University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2015
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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