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Approach to Ankle Sprains in the Emergency Department

Evaluation of Analgesic Treatments for Ankle Sprains in the Emergency Department

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06563271
Enrollment
150
Registered
2024-08-20
Start date
2023-12-01
Completion date
2024-06-01
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains

Keywords

Range of motion, Numerical Rating Scale

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.

Interventions

DRUGDexketoprofen Trometamol 50 Mg/mL Solution for Injection

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

DRUGIbuprofen 100 MG/ML Solution for Injection

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).

DRUGParacetamol 10 Mg/mL Solution for Injection

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

DRUGisotonic saline

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

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.*Patient's pain level, NRS Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatmentNumeric 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.
To evaluate the effectiveness of multimodal treatment methods on Range of Motion in ankle sprains.- 0 minute ROM before treatment - 60 minute ROM after treatmentA 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026