Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Ankle Sprain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393846
• Other study ID #: PAU2015/05
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2015
• Last updated: July 3, 2015
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Drug:
• Ketoprofen gel
Topical ketoprofen as used in gel form.
• Placebo
Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (2)

Lead Sponsor	Collaborator
Akdeniz University	Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale	Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.	30 minutes	No
Secondary	Adverse effects	Adverse effects occurred during the study is recorded to the study form.	30 minutes	Yes