Approach to Ankle Sprains in the Emergency Department

Ankara Etlik City Hospital

Status and phase: Completed; Phase 4

Conditions: Ankle Sprains

Treatments: Drug: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection; Drug: isotonic saline; Drug: Paracetamol 10 Mg/mL Solution for Injection; Drug: Ibuprofen 100 MG/ML Solution for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06563271

ES-Ankle

Details and patient eligibility

About

The aim of this study is to evaluate the short-term effects of routinely applied agents on pain and joint range of motion (ROM) in ankle sprains presenting to the emergency department (ED).

Full description

It is aimed to examine the effects of intravenous (IV) 50 mg dexketoprofen, IV ibuprofen 400mg and IV paracetamol 10 mg on pain and joint range of motion. To determine the effects of these agents on pain, the easily applicable Numerical Rating Scale (NRS) and Wong-Baker Faces Pain Rating Scale will be used. A standard handheld half-circle goniometer will be utilized to calculate active ankle joint ROM.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18 years and older who present to the emergency department within the first 72 hours after ankle sprain.
• Grade 1 (mild) and Grade 2 (moderate) ankle sprains.
• Exclusion of fractures and dislocations (after X-ray according to Ottawa rules).
• Absence of muscle-tendon ruptures.
• Absence of vascular and nerve injuries.
• Absence of open wounds and burns.
• Stable vital signs.
• Patients who provide written and verbal consent.

Exclusion criteria

• Patients who did not present to the emergency department within the first 72 hours after ankle sprain.
• Grade 3 (severe) ankle sprains.
• Multiple traumas.
• Pregnancy or suspected pregnancy.
• Ankle fractures and dislocations.
• Forensic cases.
• History of previous ankle surgery or fracture.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Group Dexketoprofen

Active Comparator group

Description:

Dexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).

Treatment:

Drug: isotonic saline

Drug: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection

Group Ibuprofen

Active Comparator group

Description:

Ibuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).

Treatment:

Drug: Ibuprofen 100 MG/ML Solution for Injection

Drug: isotonic saline

Group Paracetamol

Active Comparator group

Description:

Paracetamol 10 mg/ml will be administered parenterally.

Treatment:

Drug: Paracetamol 10 Mg/mL Solution for Injection