Low Back Pain, MechanicalPhase 4NCT04609254
Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain
A Phase 4 study testing Paracetamol, Dexketoprofen and Ibuprofen in people with Low Back Pain, Mechanical, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Non-Traumatic Acute Low Back Pain The objective of the study is compare the efficacy of intravenous dexketoprofen,ibuprofen with paracetamol in the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Paracetamol, Dexketoprofen and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2018to 15 Sep 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger Isolated non traumatic musculoskeletal pain Patients who agree to work and receive the approval VAS (visual analog scale) score>5.
Who cannot join
- • Patients with severe liver, kidney,pulmonary and cardiac heartfailure
- To be Pregnancy and breast-feeding
- Have received analgesics in the last 6hours
- Patients of childbearing age who are not using a birth control method.
- Patients with neurological deficits
- Patients with cardiac chest pain
Show all 12Show fewer
- Patients with chronic pain
- Patients with pre-existing ibuprofen, dexketoprofen and paracetamolinduced gastrointestinal bleeding and perforation
- Patients with reflected pain
- Patients with neoplastic pain
- Patients with an allergy trait (ibuprofen, paracetamol and dexketoprofen)
- Illiterates and patients with vision problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effectiveness of Intravenous Paracetamol, Dexketoprofen and Ibuprofen In The Treatment of Non-Traumatic Acute Low Back Pain In The Emergency Department
- Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Non-Traumatic Acute Low Back Pain
- The objective of the study is compare the efficacy of intravenous dexketoprofen,ibuprofen with paracetamol in the treatment of Non-Traumatic Acute Low Back Pain
Read the detailed description
- This is the randomized double blinded clinical trial to compare the efficacy of these three drugs in this clinical setting.
- A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital
- Study personnel (emergency physicians and nurses) were trained before the study.
- When intravenous drugs (Paracetamol, Dexketoprofen and ibuprofen) was being recommended, an eligibility checklist was completed by the attending physician.
- If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial Non-Traumatic Acute Low Back Pain severity ratings with visual analog scale (VAS) were recorded.
- The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
- All patients eligible for the study were randomized to one of three groups:
First Group: 1000 mg of paracetamol (parol 1000mg vial-atabay chemistry-İstanbul ) intravenous (IV) was given 71 patients, Second Group: dexketoprofen 50 mg ( arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, third group: 400 mg İbuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group. Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study.
- Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations
- The allocation list was kept by the emergency nurse. Patients received the paracetamol,dexketoprofen,ibuprofen medication schemes according to their random allocations.
- After enrollment and recording of baseline information, the next numbered study drug pack was obtained, and administered intravenously.
- Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
- One researcher blinded to patient allocation observed the whole procedure and recorded the Non-Traumatic Acute Low Back Pain scores.
- Patients in three groups received three types of medication in a similar manner, thus ensuring double blind.
Non-Traumatic Acute Low Back Pain scores were recorded at 0, 15, 30 and 60 min on a VAS of 1 to 100
- During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Paracetamol, Dexketoprofen, Ibuprofen
- Keywords
- paracetamol, dexketoprofen, ibuprofen, emergency department, low back pain
- Medical subject headings
- Low Back Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Perfalgan
1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,
DexketoprofenDrug
Also called ASEKET, DARKIN, DEXALGIN, DESTIYO
dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,
IbuprofenDrug
Also called İntrafen
400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group.
| Study group | Role | What they receive |
|---|---|---|
| First Group | Experimental | 1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients, Receives: Drug: Paracetamol |
| Second Group | Experimental | dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, Receives: Drug: Dexketoprofen |
| Third group | Experimental | 400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Non-Traumatic Acute Low Back Pain on the Visual Analog Scale at 60 minutes
Measured: Baseline and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start15 Dec 2018
- Primary completion15 Apr 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Turkcuer, Pamukkale University
- Investigators
- Cansu Dogan, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609254
- Sponsor's protocol ID
- 2019TIPF007
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be made available to other researchers whenever they need it.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effectiveness of Intravenous Paracetamol, Dexketoprofen and Ibuprofen In The Treatment of Non-Traumatic Acute Low Back Pain In The Emergency Department
- ClinicalTrials.gov ID
- NCT04609254
- Acronym / sponsor ID
- 2019TIPF007
- Conditions
- Low Back Pain, Mechanical
- Keywords
- paracetamol, dexketoprofen, ibuprofen, emergency department, low back pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 30 Oct 2020 (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.
- Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Non-Traumatic Acute Low Back Pain
- The objective of the study is compare the efficacy of intravenous dexketoprofen,ibuprofen with paracetamol in the treatment of Non-Traumatic Acute Low Back Pain
Detailed description
- This is the randomized double blinded clinical trial to compare the efficacy of these three drugs in this clinical setting.
- A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital
- Study personnel (emergency physicians and nurses) were trained before the study.
- When intravenous drugs (Paracetamol, Dexketoprofen and ibuprofen) was being recommended, an eligibility checklist was completed by the attending physician.
- If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial Non-Traumatic Acute Low Back Pain severity ratings with visual analog scale (VAS) were recorded.
- The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
- All patients eligible for the study were randomized to one of three groups:
First Group: 1000 mg of paracetamol (parol 1000mg vial-atabay chemistry-İstanbul ) intravenous (IV) was given 71 patients, Second Group: dexketoprofen 50 mg ( arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, third group: 400 mg İbuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group. Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study.
- Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations
- The allocation list was kept by the emergency nurse. Patients received the paracetamol,dexketoprofen,ibuprofen medication schemes according to their random allocations.
- After enrollment and recording of baseline information, the next numbered study drug pack was obtained, and administered intravenously.
- Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
- One researcher blinded to patient allocation observed the whole procedure and recorded the Non-Traumatic Acute Low Back Pain scores.
- Patients in three groups received three types of medication in a similar manner, thus ensuring double blind.
Non-Traumatic Acute Low Back Pain scores were recorded at 0, 15, 30 and 60 min on a VAS of 1 to 100
- During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First Group | Experimental | Drug: Paracetamol1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients, |
| Second Group | Experimental | Drug: Dexketoprofendexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, |
| Third group | Experimental | Drug: Ibuprofen400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger Isolated non traumatic musculoskeletal pain Patients who agree to work and receive the approval VAS (visual analog scale) score>5.
Key exclusion criteria (12 listed)
- • Patients with severe liver, kidney,pulmonary and cardiac heartfailure
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 |
|---|---|---|
| ParacetamolAlso: Perfalgan1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients, | Drug | First Group |
| DexketoprofenAlso: ASEKET, DARKIN, DEXALGIN, DESTIYOdexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, | Drug | Second Group |
| IbuprofenAlso: İntrafen400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group. | Drug | Third group |
Primary outcome
Change From Baseline in Non-Traumatic Acute Low Back Pain on the Visual Analog Scale at 60 minutes
Time frame: Baseline and 60 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 30 Oct 2020.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be made available to other researchers whenever they need it.
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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.
Cansu Dogan, MD principal investigator
Pamukkale University
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 Paracetamol, Dexketoprofen and Ibuprofen in people with Low Back Pain, Mechanical, run by Pamukkale University 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 12 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 30 Oct 2020. 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?
Change From Baseline in Non-Traumatic Acute Low Back Pain on the Visual Analog Scale at 60 minutes (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 30 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.