Approach to Ankle Sprains in the Emergency Department

Ankara Etlik City Hospital150 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Ankle Sprains

Interventions

Dexketoprofen Trometamol 50 Mg/mL Solution for InjectionDRUG

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

Ibuprofen 100 MG/ML Solution for InjectionDRUG

Ibuprofen 100 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). Group P: Paracetamol 10 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).

Paracetamol 10 Mg/mL Solution for InjectionDRUG

Paracetamol 10 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Outcomes

Primary Outcomes

To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.

Numeric Rang Scale (NRS) will be used to assess effects on pain. NRS: This scale uses 11 numbers from 0 to 10 to measure pain intensity, where 0 represents "No pain" and 10 represents "Worst (unbearable) pain."

Time frame: *Patient's pain level, NRS Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment

To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.

Wong-Baker FACES pain rating scale (WBS) will be used to assess effects on pain. WBS: This scale uses a series of faces ranging from a smiling face representing "No pain" to a crying face representing "Worst pain" to visually express the intensity of pain.

Time frame: *Wong-Baker Faces Pain Rating Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment

To evaluate the effectiveness of multimodal treatment methods on Range of Motion in ankle sprains.

A standard handheld goniometer will be used to calculate Range of Motion (ROM) measurements. The aim is to determine the effects of multimodal treatment methods routinely applied in emergency services on pain and range of motion and to reveal their superiority over each other, if any. (Normal ROM values: 20° for dorsiflexion, 45° for plantar flexion)

Time frame: - 0 minute ROM before treatment - 60 minute ROM after treatment

Data from ClinicalTrials.gov

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