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Status unknownNCT02491736Updated Dec 3, 2015

Ketoprofen Gel vs Placebo in Children With Ankle Sprain

A Phase 4 interventional study of Ketoprofen and Placebo in Ankle Sprain, sponsored by Akdeniz University. Status unknown at 1 site in Turkey. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by Akdeniz University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study summary

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

Read the detailed description

Ankle sprains may be associated with soft tissue injuries and fractures. Although diagnostic modalities are important, alleviation of pain is also a part of emergency department management. The aim of this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain to the emergency department.

02

Conditions studied

  • Ankle Sprain
03

In context

Sprains and Strains

217 studies on the registry are indexed under Sprains and Strains; 44 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 166 interventional studies indexed under Sprains and Strains.

Browse Sprains and Strains studies →

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with ankle sprain
  • Patients over 8 and lower than 18 years old

Exclusion criteria

Exclusion Criteria:

  • Ankle sprain more than 24 hours
  • visual analogue scale score lower than 40mm
  • Allergy to the study drug
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    ketoprofen

    2.5% ketoprofen gel

    Drug: Ketoprofen

  • Placebo comparator
    Placebo

    Placebo gel

    Other: Placebo

Interventions

  • DrugKetoprofen

    2.5% ketoprofen gel

    Also known as: Fastjel

  • OtherPlacebo

    Placebo gel

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What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    Measurement of pain reduce at 30 minutes by visual analogue scale

    Time frame: 30 minutes

Secondary outcomes

  1. Adverse effects

    Time frame: 30 minutes

07

Study locations

1 of 1 sites recruiting
  • Pamukkale University
    Denizli, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02491736
Lead sponsor
Akdeniz University
Responsible party
Sponsor
First posted
Jul 8, 2015
Start date
Jun 2015
Primary completion
Jan 2016 (estimated)
Completion
Jan 2016 (estimated)
Last update
Dec 3, 2015

Study contacts

Aysel Özkan
Contact
karek@pau.edu.tr
00902582961758
Mustafa Serinken, MD
study chair · Pamukkale University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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