Ketoprofen Gel vs Placebo in Children With Ankle Sprain

Ketoprofen Gel vs Placebo in Children Presented With Ankle Sprain to the Emergency Department: A Randomised Controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02491736

Enrollment

100

Registered

2015-07-08

Start date

2015-06-30

Completion date

2016-01-31

Last updated

2015-12-03

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

Conditions

Ankle Sprain

Brief summary

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

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.

Interventions

DRUGKetoprofen

2.5% ketoprofen gel

OTHERPlacebo

Placebo gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Visual Analogue Scale	30 minutes	Measurement of pain reduce at 30 minutes by visual analogue scale

Secondary

Measure	Time frame
Adverse effects	30 minutes

Countries

Turkey (Türkiye)

Contacts

Primary ContactAysel Özkan

karek@pau.edu.tr00902582961758

Outcome results

None listed

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