Evaluation of Analgesic Treatments for Ankle Sprains in the Emergency Department
Overview
- Phase
- Phase 4
- Intervention
- Dexketoprofen Trometamol 50 Mg/mL Solution for Injection
- Conditions
- Ankle Sprains
- Sponsor
- Ankara Etlik City Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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).
Detailed 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.
Investigators
Emine Sarcan
Doctor
Ankara Etlik City Hospital
Eligibility Criteria
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.
Arms & Interventions
Group Dexketoprofen
Dexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Intervention: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection
Group Dexketoprofen
Dexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Intervention: isotonic saline
Group Ibuprofen
Ibuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Intervention: Ibuprofen 100 MG/ML Solution for Injection
Group Ibuprofen
Ibuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Intervention: isotonic saline
Group Paracetamol
Paracetamol 10 mg/ml will be administered parenterally.
Intervention: Paracetamol 10 Mg/mL Solution for Injection
Outcomes
Primary Outcomes
To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.
Time Frame: *Wong-Baker Faces Pain Rating Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment
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.
To evaluate the effectiveness of multimodal treatment methods on Range of Motion in ankle sprains.
Time Frame: - 0 minute ROM before treatment - 60 minute ROM after treatment
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)