Low Back PainPhase 4NCT01422291
IV Paracetamol, Dexketoprofen or Morphine for the Treatment of Low Back Pain
A Phase 4 study testing paracetamol, morphine and Dexketoprofen in people with Low Back Pain, run by Pamukkale University.
Trial summary
This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- paracetamol, morphine and Dexketoprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2011
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adults (aged 16 to 55 years) with acute low back pain were eligible for inclusion in the study- -
Who cannot join
- Exclusion criteria included known allergy or contraindication to morphine, paracetamol,dexketoprofen or any opioid analgesic
- Hemodynamic instability
- Fever (temperature >38°C [100.4°F])
- Evidence of peritoneal inflammation
- Documented or suspected pregnancy
- Known or suspected aortic dissection or aneurysm, lombar disc hernia
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- Use of any analgesic within 6 hours of ED presentation
- Previous study enrollment.
- Patients with known renal, pulmonary, cardiac, or hepatic failure, as well as those with renal transplantation, were also excluded.
About this study
Official title: Pamukkale University Medical School,Dept. of Emergency Medicine
This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.
Read the detailed description
Study Design and Setting:
This is a single-center, prospective, randomized, double-blind, clinical trial performed in an ED of a tertiary care hospital with annual census of approximately 37.000 visits. The local ethics committee approved the study.
Interventions:
We conducted a randomized, controlled clinical trial comparing single intravenous doses of paracetamol (1 g), dexketoprofen (50 mg) and morphine (0.1 mg/kg) for patients presenting to the emergency department (ED) with suspected low back pain. Subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg). We compared changes in pain intensity 30 minutes after treatment.
Methods of Measurements:
Subjects reported pain intensity on both a 100-mm visual analogue scale (limited by 'no pain' and 'the worst pain') and a 4-point verbal rating scale (no pain, mild, moderate, or severe pain) just before the drug administration, 15th minutes and 30th minutes after the study drug administration. The demographic features of study patients and adverse effects, nausea, vomiting, dizziness, vertigo, headache, hypotension, altered mental status, allergic reaction, itching, urinary retention, thoracic rigidity, respiratory depression and dry mouth, were recorded to the study form.
Outcome Measures The primary outcome measure was the pain reduction in VAS and VRS at 15th and 30th minutes. Secondary outcome measures were the need for rescue drug and the presence of any adverse event.
Primary Data Analysis:
The present study was planned as a superiority trial. When the 20 mm difference in VAS is accepted as clinically significant and the standard deviation is accepted as 25 mm, 35 patients are needed with each group with 95% power. All the analysis were implemented according to the intention to treat analysis. The precise of differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).
- Conditions
- Low Back Pain
- Being tested
- paracetamol, morphine, Dexketoprofen, Paracetamole
- Keywords
- Low back pain, paracetamol, dexketoprofen, morphine
- 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
1 gr
morphineDrug
Also called Morphine CHL 0.01 gr
0.1mg/kg intravenous in 100 ml serum physiologic
DexketoprofenDrug
Also called Arveles
50 mg
ParacetamoleDrug
Also called Perfalgan
1 gr
| Study group | Role | What they receive |
|---|---|---|
| morphine | Active comparator | Not described Receives: Drug: Paracetamole |
| Paracetamole, dexketoprofen | Experimental | Paracetamole, dexketoprofen Receives: Drug: paracetamol; Drug: morphine; Drug: Dexketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in visual analogue scale
The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered
Measured: 15 minutes interval
Secondary outcomes (1)
Adverse events.
30 minutes after the study drug administered
Measured: 30 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
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
- NCT01422291
- Sponsor's protocol ID
- serinken 002
- Status last verified
- Aug 2011
- First submitted
- 22 Aug 2011
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pamukkale University Medical School,Dept. of Emergency Medicine
- ClinicalTrials.gov ID
- NCT01422291
- Acronym / sponsor ID
- serinken 002
- Conditions
- Low Back Pain
- Keywords
- Low back pain, paracetamol, dexketoprofen, morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Aug 2011 (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.
This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.
Detailed description
Study Design and Setting:
This is a single-center, prospective, randomized, double-blind, clinical trial performed in an ED of a tertiary care hospital with annual census of approximately 37.000 visits. The local ethics committee approved the study.
Interventions:
We conducted a randomized, controlled clinical trial comparing single intravenous doses of paracetamol (1 g), dexketoprofen (50 mg) and morphine (0.1 mg/kg) for patients presenting to the emergency department (ED) with suspected low back pain. Subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg). We compared changes in pain intensity 30 minutes after treatment.
Methods of Measurements:
Subjects reported pain intensity on both a 100-mm visual analogue scale (limited by 'no pain' and 'the worst pain') and a 4-point verbal rating scale (no pain, mild, moderate, or severe pain) just before the drug administration, 15th minutes and 30th minutes after the study drug administration. The demographic features of study patients and adverse effects, nausea, vomiting, dizziness, vertigo, headache, hypotension, altered mental status, allergic reaction, itching, urinary retention, thoracic rigidity, respiratory depression and dry mouth, were recorded to the study form.
Outcome Measures The primary outcome measure was the pain reduction in VAS and VRS at 15th and 30th minutes. Secondary outcome measures were the need for rescue drug and the presence of any adverse event.
Primary Data Analysis:
The present study was planned as a superiority trial. When the 20 mm difference in VAS is accepted as clinically significant and the standard deviation is accepted as 25 mm, 35 patients are needed with each group with 95% power. All the analysis were implemented according to the intention to treat analysis. The precise of differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morphine | Active comparator | Drug: Paracetamole |
| Paracetamole, dexketoprofen | Experimental | Drug: paracetamol, Drug: morphine, Drug: DexketoprofenParacetamole, dexketoprofen |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adults (aged 16 to 55 years) with acute low back pain were eligible for inclusion in the study- -
Key exclusion criteria (9 listed)
- Exclusion criteria included known allergy or contraindication to morphine, paracetamol,dexketoprofen or any opioid analgesic
- Hemodynamic instability
- Fever (temperature >38°C [100.4°F])
- Evidence of peritoneal inflammation
- Documented or suspected pregnancy
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: Perfalgan1 gr | Drug | Paracetamole, dexketoprofen |
| morphineAlso: Morphine CHL 0.01 gr0.1mg/kg intravenous in 100 ml serum physiologic | Drug | Paracetamole, dexketoprofen |
| DexketoprofenAlso: Arveles50 mg | Drug | Paracetamole, dexketoprofen |
| ParacetamoleAlso: Perfalgan1 gr | Drug | morphine |
Primary outcome
Reduction in visual analogue scale
Time frame: 15 minutes interval
The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered
1 secondary outcome
Adverse events.
Time frame: 30 minutes after
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 23 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paracetamol, morphine and Dexketoprofen 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 1 inclusion and 9 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 23 Aug 2011. 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?
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?
Reduction in visual analogue scale (time frame: 15 minutes interval). 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 23 Aug 2011.