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Approach to Ankle Sprains in the Emergency Department

Registration Number
NCT06563271
Lead Sponsor
Ankara Etlik City Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group Dexketoprofenisotonic salineDexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Group Ibuprofenisotonic salineIbuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Group ParacetamolParacetamol 10 Mg/mL Solution for InjectionParacetamol 10 mg/ml will be administered parenterally.
Group IbuprofenIbuprofen 100 MG/ML Solution for InjectionIbuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Group DexketoprofenDexketoprofen Trometamol 50 Mg/mL Solution for InjectionDexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Primary Outcome Measures
NameTimeMethod
To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.*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.- 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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ankara Etlik City Hospital

🇹🇷

Ankara, Yenimahalle, Turkey

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