PainPhase 4NCT06060236
Dexketoprofen and Ibuprofen in Long Bone Fractures
A Phase 4 study testing Ibuprofen 800 mg and Dexketoprofen in people with Pain and Bone Fracture, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the efficacy of ibuprofen and dexketoprofen, two common analgesic drugs used in pain control in patients with long bone fractures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Bone Fracture
- What is being tested?
- Ibuprofen 800 mg and Dexketoprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years
- Patients under 80 years of age
- Patients who agreed to participate in the study
- One of the tibia, femur and humerus bones is broken
- Patients with a VAS score of 50 and above
- Patients with no other injuries requiring emergency surgery
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- Previously known adverse reactions to the active ingredient of the drugs to be used patients with no history
- Conscious patients
- Oriented cooperative patients
Who cannot join
- Patients under the age of 18 and over the age of 80
- Patients who did not agree to participate in the study
- Patients with vital signs outside the normal limits
- Patients with a history of adverse reactions to known NSAIDs
- Those who cannot determine the severity of pain on the VAS
- Patients with a VAS Score of 50 mm or less
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- Those with other orthopedic injuries pregnant women
- Those with advanced systemic disease
- Those with malignancy
- Those with chronic liver and kidney disease
- Those who use neuro-psychiatric drugs with sedative and analgesic effects
- Those with a history of psychological and neurological diseases
- Patients using analgesics 8 hours before the examination
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent Şehir Hastanesi
Ankara, 06170
Safa Dönmez, drsafa0131@gmail.com
Safa Dönmez
About this study
Official title: Comparison of Analgesic Efficacy of Dexketoprofen and Ibuprofen in Long Bone Fractures: Randomised Controlled Double-blind Study
The aim of this study was to compare the efficacy of ibuprofen and dexketoprofen, two common analgesic drugs used in pain control in patients with long bone fractures.
Read the detailed description
Long bone fractures are the fractures of long bones (tibia, femur, humerus) in the human body. Such fractures usually occur as a result of trauma and are manifested by symptoms such as pain, swelling, bruising and limitation of movement. Effective control of pain can help the patient relax and facilitate the healing process. Ibuprofen and dexketoprofen, which belong to the class of non-steroidal anti-inflammatory drugs (NSAID), are among the analgesics commonly used in the pain management of all fractures. These drugs are thought to be able to relieve pain, reduce inflammation, and help patients move. However, each patient's individual response and tolerance may differ, so the efficacy and side effects of each drug may vary from patient to patient. This makes it difficult to determine which analgesic is more effective and safe in clinical practice. The fact that it is a subject that has not been done much in the literature has led us to do this study.
- Conditions
- Pain, Bone Fracture
- Being tested
- Ibuprofen 800 mg, Dexketoprofen
- Keywords
- Long bone fracture, ibuprofen, dexketoprofen, pain
- Medical subject headings
- Pain, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 800 mgDrug
Ibuprofen 800 Mg İv
DexketoprofenDrug
Dexketoprofen 50 Mg İV
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen | Experimental | ibuprofen intravenous 800 mg Receives: Drug: Ibuprofen 800 mg |
| dexketoprofen | Experimental | dexketoprofen intravenous 50 mg Receives: Drug: Dexketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
The pain is determined using a 100 mm scale. Patients are instructed to mark the level of pain they experience, with 0 mm indicating no pain and 100 mm indicating the presence of maximum pain.
Measured: 120 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Dönmez, Ankara City Hospital Bilkent
- Investigators
- Safa Dönmez, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060236
- Sponsor's protocol ID
- E2-23-4743
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.
PubMed 25349008Friday JH, Kanegaye JT, McCaslin I, Zheng A, Harley JR. Ibuprofen provides analgesia equivalent to acetaminophen-codeine in the treatment of acute pain in children with extremity injuries: a randomized clinical trial. Acad Emerg Med. 2009 Aug;16(8):711-6. doi: 10.1111/j.1553-2712.2009.00471.x. Epub 2009 Jul 14.
PubMed 19624576
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Dexketoprofen and Ibuprofen in Long Bone Fractures: Randomised Controlled Double-blind Study
- ClinicalTrials.gov ID
- NCT06060236
- Acronym / sponsor ID
- E2-23-4743
- Conditions
- Pain, Bone Fracture
- Keywords
- Long bone fracture, ibuprofen, dexketoprofen, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 29 Sep 2023 (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 was to compare the efficacy of ibuprofen and dexketoprofen, two common analgesic drugs used in pain control in patients with long bone fractures.
Detailed description
Long bone fractures are the fractures of long bones (tibia, femur, humerus) in the human body. Such fractures usually occur as a result of trauma and are manifested by symptoms such as pain, swelling, bruising and limitation of movement. Effective control of pain can help the patient relax and facilitate the healing process. Ibuprofen and dexketoprofen, which belong to the class of non-steroidal anti-inflammatory drugs (NSAID), are among the analgesics commonly used in the pain management of all fractures. These drugs are thought to be able to relieve pain, reduce inflammation, and help patients move. However, each patient's individual response and tolerance may differ, so the efficacy and side effects of each drug may vary from patient to patient. This makes it difficult to determine which analgesic is more effective and safe in clinical practice. The fact that it is a subject that has not been done much in the literature has led us to do this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ibuprofen | Experimental | Drug: Ibuprofen 800 mgibuprofen intravenous 800 mg |
| dexketoprofen | Experimental | Drug: Dexketoprofendexketoprofen intravenous 50 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- over 18 years
- Patients under 80 years of age
- Patients who agreed to participate in the study
- One of the tibia, femur and humerus bones is broken
- Patients with a VAS score of 50 and above
Key exclusion criteria (13 listed)
- Patients under the age of 18 and over the age of 80
- Patients who did not agree to participate in the study
- Patients with vital signs outside the normal limits
- Patients with a history of adverse reactions to known NSAIDs
- Those who cannot determine the severity of pain on the VAS
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 |
|---|---|---|
| Ibuprofen 800 mgIbuprofen 800 Mg İv | Drug | ibuprofen |
| DexketoprofenDexketoprofen 50 Mg İV | Drug | dexketoprofen |
Primary outcome
Visual analog scale
Time frame: 120 minute
The pain is determined using a 100 mm scale. Patients are instructed to mark the level of pain they experience, with 0 mm indicating no pain and 100 mm indicating the presence of maximum pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Results publication: PubMed 25349008Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.
- Results publication: PubMed 19624576Friday JH, Kanegaye JT, McCaslin I, Zheng A, Harley JR. Ibuprofen provides analgesia equivalent to acetaminophen-codeine in the treatment of acute pain in children with extremity injuries: a randomized clinical trial. Acad Emerg Med. 2009 Aug;16(8):711-6. doi: 10.1111/j.1553-2712.2009.00471.x. Epub 2009 Jul 14.
- Individual participant dataSharing planned: No
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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.
Safa Dönmez, MD principal investigator
Ankara City Hospital Bilkent
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 Ibuprofen 800 mg and Dexketoprofen in people with Pain and Bone Fracture, run by Ankara City Hospital Bilkent 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 9 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 2 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safa Dönmez, MD (+905537515545, drsafa0131@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 120 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06060236, which also lists 2 linked publications.
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 2 Oct 2023.