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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mustafa Serinken, Pamukkale University
ClinicalTrials.gov Identifier:
NCT01422291
First received: August 22, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

August 22, 2011
August 22, 2011
January 2011
July 2011   (final data collection date for primary outcome measure)
Reduction in visual analogue scale [ Time Frame: 15 minutes interval ] [ Designated as safety issue: No ]
The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered
Same as current
No Changes Posted
Adverse events. [ Time Frame: 30 minutes after ] [ Designated as safety issue: Yes ]
30 minutes after the study drug administered
Same as current
Not Provided
Not Provided
 
IV Paracetamol, Dexketoprofen or Morphine for the Treatment of Low Back Pain
Pamukkale University Medical School,Dept. of Emergency Medicine

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.

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Low Back Pain
  • 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
  • Drug: Paracetamole
    1 gr
    Other Name: Perfalgan
  • Drug: Morphine
    0.1mg/kg intravenous in 100 ml serum physiologic
    Other Name: Morphine
  • Active Comparator: morphine
    Intervention: Drug: Paracetamole
  • Experimental: Paracetamole, dexketoprofen
    Paracetamole, dexketoprofen
    Interventions:
    • Drug: paracetamol
    • Drug: morphine
    • Drug: Dexketoprofen
    • Drug: Morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
16 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01422291
serinken 002
No
Mustafa Serinken, Pamukkale University
Pamukkale University
Not Provided
Not Provided
Pamukkale University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP