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

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ClinicalTrials.gov Identifier: NCT01422291
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : August 23, 2011
Information provided by (Responsible Party):
Mustafa Serinken, Pamukkale University

Brief 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: paracetamol Drug: morphine Drug: Dexketoprofen Drug: Paracetamole Phase 4

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.


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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: morphine Drug: Paracetamole
1 gr
Other Name: Perfalgan

Experimental: Paracetamole, dexketoprofen
Paracetamole, dexketoprofen
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Adverse events. [ Time Frame: 30 minutes after ]
    30 minutes after the study drug administered

Information from the National Library of Medicine

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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.
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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
Keywords provided by Mustafa Serinken, Pamukkale University:
Low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Dexketoprofen trometamol
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents