Approach to Ankle Sprains in the Emergency Department

NCT06563271 | Completed Phase 4

• 1 other identifier: ES-Ankle
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Ankle Sprains

Keywords

Range of motion; Numerical Rating Scale

Outcome Measures

Primary Outcomes (3)

• 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."

  *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.

  *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)

  - 0 minute ROM before treatment - 60 minute ROM after treatment

Study Arms (3)

Group Dexketoprofen

ACTIVE COMPARATOR

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

Drug: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection; Drug: isotonic saline

Group Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).

Drug: Ibuprofen 100 MG/ML Solution for Injection; Drug: isotonic saline

Group Paracetamol

ACTIVE COMPARATOR

Paracetamol 10 mg/ml will be administered parenterally.

Drug: Paracetamol 10 Mg/mL Solution for Injection

Interventions

Dexketoprofen Trometamol 50 Mg/mL Solution for Injection DRUG

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

Group Dexketoprofen

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).

Group Ibuprofen

Paracetamol 10 Mg/mL Solution for Injection DRUG

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

Group Paracetamol

isotonic saline DRUG

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

Group Dexketoprofen; Group Ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

dexketoprofen trometamol; Solutions; Injections; Ibuprofen; Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ahmet B. Erdem

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 20, 2024
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

TU (1)