|Low Back Pain||Drug: paracetamol Drug: morphine Drug: Dexketoprofen Drug: Paracetamole||Phase 4|
|Study Design:||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|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: morphine||
Other Name: Perfalgan
Experimental: Paracetamole, dexketoprofen
Other Name: PerfalganDrug: morphine
0.1mg/kg intravenous in 100 ml serum physiologic
Other Name: Morphine CHL 0.01 grDrug: Dexketoprofen
Other Name: Arveles
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.
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).