Low Back PainPhase 4NCT02836509
Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department
A Phase 4 study testing Paracetamol and Ibuprofen in people with Low Back Pain, run by Pamukkale University.
Trial summary
Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for the pain treatments. The objective of the study was to assess whether intravenous Paracetamol has superior Low Back Pain reduction will compare with Ibuprofen in emergency department (ED) adults. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Paracetamol and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Mar 2017
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who presented with complaints of low back pain to the emergency services ,
- Patients whose complaints have started in the last week,
- Younger than 21 years old,
- older than 80 years old,
Who cannot join
- Pretreatment linear 100-mm visual analog scale (VAS) pain score less than 40 mm,
- Patients who have drop foot, paralysis and other neurological symptoms in physical examination.
- Patients with blood pressure less than 90mmHg in the arrival of emergency services.
- Patients with malignancy, cauda equina syndrome, ankylosing spondylitis, rheumatoid arthritis or inflammatory arthritis contain any of the disease in his/her CV.
- Patients with any history of chronic pain syndrome.
- Patients who receive pain killers, antidepressants, anticonvulsants, muscle relaxants, steroids within 6 hours before the ED visit,
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- Patients have a history of active peptic ulcer disease,
- Patients who have signs of peritoneal irritation,
- Patients had a fever (>37.9)
- Allergy or previous adverse reaction to the studied drugs(Ibuprofen, Paracetamol), received agents to inhibit the secretion of acid (PPIs or histamine-2 receptor antagonists), antispasmodics, or nonsteroidal anti-inflammatory drugs
- were pregnant or breast-feeding,
- inability to comprehend the VAS evaluation,
- or refused to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial
Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for the pain treatments.
The objective of the study was to assess whether intravenous Paracetamol has superior Low Back Pain reduction will compare with Ibuprofen in emergency department (ED) adults.
Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.
Read the detailed description
Paracetamol and Ibuprofen each relieve pain with different mechanisms.
Paracetamol is termed a simple analgesic and an antipyretic. Despite enduring assertions that it acts by inhibition of cyclooxygenase (COX)-mediated production of prostaglandins, unlike non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen is the most commonly used and most frequently prescribed NSAID. It is a non-selective inhibitor of cyclo-oxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2).4 Although its anti inflammatory properties may be weaker than those of some other NSAIDs, it has a prominent analgesic and antipyretic role.
In the investigators trial; The investigators aimed to compare intravenous Paracetamol and Ibuprofen in patient with Low Back Pain
- All patients eligible for the study were randomized to one of two groups:
- First Group: 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
- 100 ml of saline is removed before the addition of the 100 ml paracetamol (Perfalgan, Bristol Myers, Italy) to be the same volume.
- Second Group: 800mg Ibuprofen (Intrafen Flk, Gen drug, Turkey) in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
- Drug packs 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 or 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 as a infusion over 5 minutes.
- Randomization was achieved by using computer software to generate random numbers.
- One researcher blinded to patient allocation observed the whole procedure and recorded the Low Back Pain scores.
- Patients in both groups received two types of medication in a similar manner (for example, 150 ml normal saline given as a slow intravenous infusion over 5 minutes), thus ensuring double blinding.
- Low Back Pain scores were recorded at 0, 15, and 30 min on a VAS of 1 to 10
- Rescue medication is given within 30 minutes after study drug administration if the patients say yes that question "Do you need any additional analgesic requirement".
- All other medications required during the study also were recorded.
- Conditions
- Low Back Pain
- Being tested
- Paracetamol, Ibuprofen
- Keywords
- Low Back Pain, Ibuprofen, Paracetamol, Emergency Medicine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called PERFALGAN, PARTEMOL, PAROL
1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
IbuprofenDrug
Also called intrafen, Caldolon
800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| paracetamol group | Experimental | First Group: 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes. (100 ml of saline is removed before the addition of the 100 ml paracetamol to be the same volume) Receives: Drug: Paracetamol |
| Ibuprofen group | Experimental | Second Group: 800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Low Back Pain on the Visual Analog Scale
Measured: Low Back Pain scores will be recorded at 0, 15, and 30 min on a VAS of 1 to 10
Secondary outcomes (1)
Adverse events
30th minutes after the study drug administered
Measured: 30th minutes after the study drug administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Serinken, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836509
- Sponsor's protocol ID
- LBPainIvsP
- Status last verified
- Jul 2016
- First submitted
- 1 Jul 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT02836509
- Acronym / sponsor ID
- LBPainIvsP
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Ibuprofen, Paracetamol, Emergency Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- 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 Ibuprofen are widely used by emergency physicians in Turkey for the pain treatments.
The objective of the study was to assess whether intravenous Paracetamol has superior Low Back Pain reduction will compare with Ibuprofen in emergency department (ED) adults.
Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.
Detailed description
Paracetamol and Ibuprofen each relieve pain with different mechanisms.
Paracetamol is termed a simple analgesic and an antipyretic. Despite enduring assertions that it acts by inhibition of cyclooxygenase (COX)-mediated production of prostaglandins, unlike non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen is the most commonly used and most frequently prescribed NSAID. It is a non-selective inhibitor of cyclo-oxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2).4 Although its anti inflammatory properties may be weaker than those of some other NSAIDs, it has a prominent analgesic and antipyretic role.
In the investigators trial; The investigators aimed to compare intravenous Paracetamol and Ibuprofen in patient with Low Back Pain
- All patients eligible for the study were randomized to one of two groups:
- First Group: 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
- 100 ml of saline is removed before the addition of the 100 ml paracetamol (Perfalgan, Bristol Myers, Italy) to be the same volume.
- Second Group: 800mg Ibuprofen (Intrafen Flk, Gen drug, Turkey) in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
- Drug packs 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 or 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 as a infusion over 5 minutes.
- Randomization was achieved by using computer software to generate random numbers.
- One researcher blinded to patient allocation observed the whole procedure and recorded the Low Back Pain scores.
- Patients in both groups received two types of medication in a similar manner (for example, 150 ml normal saline given as a slow intravenous infusion over 5 minutes), thus ensuring double blinding.
- Low Back Pain scores were recorded at 0, 15, and 30 min on a VAS of 1 to 10
- Rescue medication is given within 30 minutes after study drug administration if the patients say yes that question "Do you need any additional analgesic requirement".
- All other medications required during the study also were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracetamol group | Experimental | Drug: ParacetamolFirst Group: 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes. (100 ml of saline is removed before the addition of the 100 ml paracetamol to be the same volume) |
| Ibuprofen group | Experimental | Drug: IbuprofenSecond Group: 800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who presented with complaints of low back pain to the emergency services ,
- Patients whose complaints have started in the last week,
- Younger than 21 years old,
- older than 80 years old,
Key exclusion criteria (13 listed)
- Pretreatment linear 100-mm visual analog scale (VAS) pain score less than 40 mm,
- Patients who have drop foot, paralysis and other neurological symptoms in physical examination.
- Patients with blood pressure less than 90mmHg in the arrival of emergency services.
- Patients with malignancy, cauda equina syndrome, ankylosing spondylitis, rheumatoid arthritis or inflammatory arthritis contain any of the disease in his/her CV.
- Patients with any history of chronic pain syndrome.
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: PERFALGAN, PARTEMOL, PAROL1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes. | Drug | paracetamol group |
| IbuprofenAlso: intrafen, Caldolon800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes | Drug | Ibuprofen group |
Primary outcome
Reduction of Low Back Pain on the Visual Analog Scale
Time frame: Low Back Pain scores will be recorded at 0, 15, and 30 min on a VAS of 1 to 10
1 secondary outcome
Adverse events
Time frame: 30th minutes after the study drug administered
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Ibuprofen in people with Low Back Pain, run by Pamukkale University.
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 4 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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Mustafa SERINKEN, professor (505 2991497, aserinken@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Low Back Pain on the Visual Analog Scale (time frame: Low Back Pain scores will be recorded at 0, 15, and 30 min on a VAS of 1 to 10). 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 19 Jul 2016.