Ankle SprainsPhase 4NCT06563271
Approach to Ankle Sprains in the Emergency Department
A Phase 4 study testing Dexketoprofen Trometamol 50 Mg/mL Solution for Injection, Ibuprofen 100 MG/ML Solution for Injection and Paracetamol 10 Mg/mL Solution for Injection in people with Ankle Sprains, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Dexketoprofen Trometamol 50 Mg/mL Solution for Injection, Ibuprofen 100 MG/ML Solution for Injection and Paracetamol 10 Mg/mL Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 38000
About this study
Official title: Evaluation of Analgesic Treatments for 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).
Read the 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.
- Conditions
- Ankle Sprains
- Being tested
- Dexketoprofen Trometamol 50 Mg/mL Solution for Injection, Ibuprofen 100 MG/ML Solution for Injection, Paracetamol 10 Mg/mL Solution for Injection, isotonic saline
- Keywords
- Range of motion, Numerical Rating Scale
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexketoprofen Trometamol 50 Mg/mL Solution for InjectionDrug
Dexketoprofen 50 mg administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Ibuprofen 100 MG/ML Solution for InjectionDrug
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 InjectionDrug
Paracetamol 10 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
isotonic salineDrug
Ibuprofen and dexketoprofen will be administered intravenously (IV) by mixing them into 150 cc of isotonic saline.
| Study group | Role | What they receive |
|---|---|---|
| Group Dexketoprofen | Active comparator | Dexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). Receives: 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). Receives: Drug: Ibuprofen 100 MG/ML Solution for Injection; Drug: isotonic saline |
| Group Paracetamol | Active comparator | Paracetamol 10 mg/ml will be administered parenterally. Receives: Drug: Paracetamol 10 Mg/mL Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: *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.
Measured: *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)
Measured: - 0 minute ROM before treatment - 60 minute ROM after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Dec 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Sarcan, Ankara Etlik City Hospital
- Investigators
- Ahmet B. Erdem, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563271
- Sponsor's protocol ID
- ES-Ankle
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesic Treatments for Ankle Sprains in the Emergency Department
- ClinicalTrials.gov ID
- NCT06563271
- Acronym / sponsor ID
- ES-Ankle
- Conditions
- Ankle Sprains
- Keywords
- Range of motion, Numerical Rating Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Dexketoprofen | Active comparator | Drug: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection, Drug: isotonic salineDexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). |
| Group Ibuprofen | Active comparator | Drug: Ibuprofen 100 MG/ML Solution for Injection, Drug: isotonic salineIbuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). |
| Group Paracetamol | Active comparator | Drug: Paracetamol 10 Mg/mL Solution for InjectionParacetamol 10 mg/ml will be administered parenterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexketoprofen Trometamol 50 Mg/mL Solution for InjectionDexketoprofen 50 mg administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). | Drug | Group Dexketoprofen |
| Ibuprofen 100 MG/ML Solution for InjectionIbuprofen 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). | Drug | Group Ibuprofen |
| Paracetamol 10 Mg/mL Solution for InjectionParacetamol 10 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). | Drug | Group Paracetamol |
| isotonic salineIbuprofen and dexketoprofen will be administered intravenously (IV) by mixing them into 150 cc of isotonic saline. | Drug | Group Dexketoprofen, Group Ibuprofen |
Primary outcome
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."
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Related trials for Ankle Sprains
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet B. Erdem study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexketoprofen Trometamol 50 Mg/mL Solution for Injection, Ibuprofen 100 MG/ML Solution for Injection and Paracetamol 10 Mg/mL Solution for Injection in people with Ankle Sprains, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.