IV Paracetamol, Dexketoprofen or Morphine for the Treatment of Low Back Pain

Study Overview
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Brief Summary
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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
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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).

Official Title
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Pamukkale University Medical School,Dept. of Emergency Medicine

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: paracetamol
* Drug: morphine
* Drug: Dexketoprofen
* Drug: Paracetamole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: morphine<br> | Drug: Paracetamole<br>* 1 gr<br>* Other names: Perfalgan;|
| Experimental: Paracetamole, dexketoprofen<br>Paracetamole, dexketoprofen | Drug: paracetamol<br>* 1 gr<br>* Other names: Perfalgan;Drug: morphine<br>* 0.1mg/kg intravenous in 100 ml serum physiologic<br>* Other names: Morphine CHL 0.01 gr;Drug: Dexketoprofen<br>* 50 mg<br>* Other names: Arveles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in visual analogue scale | The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered | 15 minutes interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events. | 30 minutes after the study drug administered | 30 minutes after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, paracetamol, dexketoprofen, morphine