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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 23, 2011
Last Update Posted: August 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mustafa Serinken, Pamukkale University
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 Intervention Phase
Low Back Pain Drug: paracetamol Drug: morphine Drug: Dexketoprofen Drug: Paracetamole Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Mustafa Serinken, Pamukkale University:

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

Enrollment: 120
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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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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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Mustafa Serinken, Pamukkale University
ClinicalTrials.gov Identifier: NCT01422291     History of Changes
Other Study ID Numbers: serinken 002
First Submitted: August 22, 2011
First Posted: August 23, 2011
Last Update Posted: August 23, 2011
Last Verified: August 2011

Keywords provided by Mustafa Serinken, Pamukkale University:
Low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic