Rib FracturePhase 4NCT07859631
Ibuprofen Versus Dexketoprofen in Rib Fractures
A Phase 4 study testing Ibuprofen 800 mg and Dexketoprofen 50 mg in people with Rib Fracture, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the pain-relieving effects of two different nonsteroidal anti-inflammatory drugs (NSAIDs), intravenous ibuprofen and intravenous dexketoprofen, in adults who present to the emergency department with isolated rib fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture
- What is being tested?
- Ibuprofen 800 mg and Dexketoprofen 50 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 25 May 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older Presence of an isolated rib fracture after blunt thoracic trauma confirmed by non-contrast thoracic computed tomography A baseline Visual Analog Scale (VAS) pain score of at least 50 mm A Glasgow Coma Scale (GCS) score of 15 Stable vital signs
Who cannot join
- Known NSAID allergy or intolerance Pregnancy or breastfeeding Analgesic or sedative use within the preceding 12 hours Inability to complete VAS assessment because of cognitive or neuropsychiatric impairment Advanced chronic systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Ibuprofen Versus Dexketoprofen for Acute Pain Control in Isolated Rib Fractures: A Prospective, Randomized, Single-Blind Controlled Trial
The purpose of this study is to compare the pain-relieving effects of two different nonsteroidal anti-inflammatory drugs (NSAIDs), intravenous ibuprofen and intravenous dexketoprofen, in adults who present to the emergency department with isolated rib fractures. Patients with rib fractures confirmed by a computed tomography (CT) scan and experiencing moderate to severe pain will randomly receive either 800 mg of intravenous ibuprofen or 50 mg of intravenous dexketoprofen. The researchers will measure pain levels using a 100-mm Visual Analog Scale (VAS) before the treatment and at 30, 60, and 120 minutes after receiving the medication to evaluate which drug provides better pain relief. The study will also track how many patients require additional rescue pain medication and record any side effects that occur during the observation period.
Read the detailed description
This is a single-center, prospective, randomized, single-blind controlled clinical trial conducted in an emergency department setting. The primary objective is to evaluate the absolute pain reduction from baseline to 60 minutes in patients receiving either intravenous ibuprofen 800 mg or intravenous dexketoprofen 50 mg for isolated rib fractures. Eligible adult patients with CT-confirmed isolated rib fractures after blunt thoracic trauma will be randomized in a 1:1 ratio using sequentially drawn treatment envelopes prepared prior to recruitment. Patients in the ibuprofen group will receive intravenous ibuprofen 800 mg mixed in 150 mL of 0.9% sodium chloride, and patients in the dexketoprofen group will receive intravenous dexketoprofen 50 mg mixed in 150 mL of 0.9% sodium chloride. Both treatments will be administered over a period of 5 to 10 minutes. Pain intensity will be self-reported by each patient using a 100-mm Visual Analog Scale (VAS), where 0 mm represents no pain and 100 mm represents the worst imaginable pain. Assessments will occur at baseline (0 minutes) and at 30, 60, and 120 minutes post-treatment. At the 60-minute evaluation, patients who still report a VAS score of 50 mm or greater, or those whose analgesia is considered inadequate by the treating physician, will be given a rescue analgesic consisting of tramadol hydrochloride 100 mg in 500 mL of 0.9% sodium chloride administered over 30 minutes. Patients who receive rescue analgesia will remain in the study and complete their final 120-minute VAS assessment. All observed adverse events during the study timeframe will be recorded prospectively.
- Conditions
- Rib Fracture
- Being tested
- Ibuprofen 800 mg, Dexketoprofen 50 mg
- Keywords
- ibuprofen, rib fracture, dexketoprofen, analgesia, emergency department
- Medical subject headings
- Rib Fractures, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 800 mgDrug
800 mg of intravenous ibuprofen in 150 mL of 0.9% sodium chloride over 5-10 minutes.
Dexketoprofen 50 mgDrug
50 mg of intravenous dexketoprofen in 150 mL of 0.9% sodium chloride over 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Ibuprofen | Experimental | Patients randomized to receive intravenous ibuprofen 800 mg in 150 mL of 0.9% sodium chloride administered over 5-10 minutes. Receives: Drug: Ibuprofen 800 mg |
| Intravenous Dexketoprofen | Active comparator | Patients randomized to receive intravenous dexketoprofen 50 mg in 150 mL of 0.9% sodium chloride administered over 5-10 minutes. Receives: Drug: Dexketoprofen 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute pain reduction from baseline to 60 minutes (ΔVAS0-60)
Pain intensity assessed using a 100-mm Visual Analog Scale (VAS) anchored by 0 mm (no pain) and 100 mm (worst imaginable pain). Absolute pain reduction is calculated as baseline VAS minus the 60-minute VAS score.
Measured: Baseline and 60 minutes
Secondary outcomes (1)
Pain reduction at 30 minutes
Absolute and relative pain reduction calculated using the 100-mm VAS score at 30 minutes compared to baseline.
Measured: Baseline and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Jan 2024
- Primary completion25 May 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FractureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Yenal, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859631
- Sponsor's protocol ID
- E2-23-5987
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ibuprofen Versus Dexketoprofen for Acute Pain Control in Isolated Rib Fractures: A Prospective, Randomized, Single-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07859631
- Acronym / sponsor ID
- E2-23-5987
- Conditions
- Rib Fracture
- Keywords
- ibuprofen, rib fracture, dexketoprofen, analgesia, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 6 Oct 2026 (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 purpose of this study is to compare the pain-relieving effects of two different nonsteroidal anti-inflammatory drugs (NSAIDs), intravenous ibuprofen and intravenous dexketoprofen, in adults who present to the emergency department with isolated rib fractures. Patients with rib fractures confirmed by a computed tomography (CT) scan and experiencing moderate to severe pain will randomly receive either 800 mg of intravenous ibuprofen or 50 mg of intravenous dexketoprofen. The researchers will measure pain levels using a 100-mm Visual Analog Scale (VAS) before the treatment and at 30, 60, and 120 minutes after receiving the medication to evaluate which drug provides better pain relief. The study will also track how many patients require additional rescue pain medication and record any side effects that occur during the observation period.
Detailed description
This is a single-center, prospective, randomized, single-blind controlled clinical trial conducted in an emergency department setting. The primary objective is to evaluate the absolute pain reduction from baseline to 60 minutes in patients receiving either intravenous ibuprofen 800 mg or intravenous dexketoprofen 50 mg for isolated rib fractures. Eligible adult patients with CT-confirmed isolated rib fractures after blunt thoracic trauma will be randomized in a 1:1 ratio using sequentially drawn treatment envelopes prepared prior to recruitment. Patients in the ibuprofen group will receive intravenous ibuprofen 800 mg mixed in 150 mL of 0.9% sodium chloride, and patients in the dexketoprofen group will receive intravenous dexketoprofen 50 mg mixed in 150 mL of 0.9% sodium chloride. Both treatments will be administered over a period of 5 to 10 minutes. Pain intensity will be self-reported by each patient using a 100-mm Visual Analog Scale (VAS), where 0 mm represents no pain and 100 mm represents the worst imaginable pain. Assessments will occur at baseline (0 minutes) and at 30, 60, and 120 minutes post-treatment. At the 60-minute evaluation, patients who still report a VAS score of 50 mm or greater, or those whose analgesia is considered inadequate by the treating physician, will be given a rescue analgesic consisting of tramadol hydrochloride 100 mg in 500 mL of 0.9% sodium chloride administered over 30 minutes. Patients who receive rescue analgesia will remain in the study and complete their final 120-minute VAS assessment. All observed adverse events during the study timeframe will be recorded prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Ibuprofen | Experimental | Drug: Ibuprofen 800 mgPatients randomized to receive intravenous ibuprofen 800 mg in 150 mL of 0.9% sodium chloride administered over 5-10 minutes. |
| Intravenous Dexketoprofen | Active comparator | Drug: Dexketoprofen 50 mgPatients randomized to receive intravenous dexketoprofen 50 mg in 150 mL of 0.9% sodium chloride administered over 5-10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 years or older Presence of an isolated rib fracture after blunt thoracic trauma confirmed by non-contrast thoracic computed tomography A baseline Visual Analog Scale (VAS) pain score of at least 50 mm A Glasgow Coma Scale (GCS) score of 15 Stable vital signs
Key exclusion criteria (1 listed)
- Known NSAID allergy or intolerance Pregnancy or breastfeeding Analgesic or sedative use within the preceding 12 hours Inability to complete VAS assessment because of cognitive or neuropsychiatric impairment Advanced chronic systemic disease
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 mg800 mg of intravenous ibuprofen in 150 mL of 0.9% sodium chloride over 5-10 minutes. | Drug | Intravenous Ibuprofen |
| Dexketoprofen 50 mg50 mg of intravenous dexketoprofen in 150 mL of 0.9% sodium chloride over 5-10 minutes. | Drug | Intravenous Dexketoprofen |
Primary outcome
Absolute pain reduction from baseline to 60 minutes (ΔVAS0-60)
Time frame: Baseline and 60 minutes
Pain intensity assessed using a 100-mm Visual Analog Scale (VAS) anchored by 0 mm (no pain) and 100 mm (worst imaginable pain). Absolute pain reduction is calculated as baseline VAS minus the 60-minute VAS score.
1 secondary outcome
Pain reduction at 30 minutes
Time frame: Baseline and 30 minutes
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared upon reasonable request.
Related trials for Rib Fracture
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 50 mg in people with Rib 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 1 inclusion and 1 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 6 Oct 2026. 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?
Absolute pain reduction from baseline to 60 minutes (ΔVAS0-60) (time frame: Baseline and 60 minutes). 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 6 Oct 2026.