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NCT Number: NCT06563271

Approach to Ankle Sprains in the Emergency Department

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).

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Key information

Conditions

Ankle Sprains Ankle Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara Etlik City Hospital

Ankara, Yenimahalle, 38000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexketoprofen Trometamol 50 Mg/mL Solution for Injection

Drug

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

Ibuprofen 100 MG/ML Solution for Injection

Drug

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 Injection

Drug

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

Isotonic saline

Drug

Ibuprofen and dexketoprofen will be administered intravenously (IV) by mixing them into 150 cc of isotonic saline.

Primary outcomes

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

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

    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."

  2. 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.

  3. 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)

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Evaluation of Analgesic Treatments for Ankle Sprains in the Emergency Department

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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