Approach to Ankle Sprains in the Emergency Department

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

NCT02393846

Ankle Sprain

COMPLETED PHASE4

Topical Treatments for Ankle Sprains

NCT06623929

Ankle Sprain

ACTIVE_NOT_RECRUITING

HKT-500 in the Treatment of Adult Patients With Ankle Sprain

NCT00927641

Ankle Sprain

COMPLETED PHASE3

Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

NCT00573768

Ankle Sprain

COMPLETED PHASE2

Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures

NCT02967172

Pain, Postoperative Ankle Fractures

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankle Sprains

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Dexketoprofen

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

Group Type ACTIVE_COMPARATOR

Dexketoprofen Trometamol 50 Mg/mL Solution for Injection

Intervention Type DRUG

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

isotonic saline

Intervention Type DRUG

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

Group Ibuprofen

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

Group Type ACTIVE_COMPARATOR

Ibuprofen 100 MG/ML Solution for Injection

Intervention Type 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).

isotonic saline

Intervention Type DRUG

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

Group Paracetamol

Paracetamol 10 mg/ml will be administered parenterally.

Group Type ACTIVE_COMPARATOR

Paracetamol 10 Mg/mL Solution for Injection

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexketoprofen Trometamol 50 Mg/mL Solution for Injection

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

Intervention Type DRUG

Ibuprofen 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).

Intervention Type DRUG

Paracetamol 10 Mg/mL Solution for Injection

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

Intervention Type DRUG

isotonic saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes