IV Paracetamol, Dexketoprofen or Morphine for the Treatment of Low Back Pain
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| ClinicalTrials.gov Identifier: NCT01422291 |
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Recruitment Status :
Completed
First Posted : August 23, 2011
Last Update Posted : August 23, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Low Back Pain | Drug: paracetamol Drug: morphine Drug: Dexketoprofen Drug: Paracetamole | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | Pamukkale University Medical School,Dept. of Emergency Medicine |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: morphine |
Drug: Paracetamole
1 gr
Other Name: Perfalgan |
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Experimental: Paracetamole, dexketoprofen
Paracetamole, dexketoprofen
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Drug: paracetamol
1 gr
Other Name: Perfalgan Drug: morphine 0.1mg/kg intravenous in 100 ml serum physiologic
Other Name: Morphine CHL 0.01 gr Drug: Dexketoprofen 50 mg
Other Name: Arveles |
- 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
- Adverse events. [ Time Frame: 30 minutes after ]30 minutes after the study drug administered
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| Ages Eligible for Study: | 16 Years to 55 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults (aged 16 to 55 years) with acute low back pain were eligible for inclusion in the study- -
Exclusion Criteria:
- 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
- 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.
| Responsible Party: | Mustafa Serinken, Pamukkale University |
| ClinicalTrials.gov Identifier: | NCT01422291 |
| Other Study ID Numbers: |
serinken 002 |
| First Posted: | August 23, 2011 Key Record Dates |
| Last Update Posted: | August 23, 2011 |
| Last Verified: | August 2011 |
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Low back pain paracetamol dexketoprofen morphine |
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Back Pain Low Back Pain Pain Neurologic Manifestations Acetaminophen Dexketoprofen trometamol Morphine Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Analgesics, Non-Narcotic Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents |