Ketoprofen Gel vs Placebo in Children With Ankle Sprain

Akdeniz University

Status and phase: Unknown; Phase 4

Conditions: Ankle Sprain

Treatments: Other: Placebo; Drug: Ketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02491736

16445

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups, including a placebo group

ketoprofen

Experimental group

Description:

2.5% ketoprofen gel

Treatment:

Drug: Ketoprofen

Placebo

Placebo Comparator group

Description:

Placebo gel

Treatment:

Other: Placebo