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

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

Tracking Information
First Submitted Date  ICMJE August 22, 2011
First Posted Date  ICMJE August 23, 2011
Last Update Posted Date August 23, 2011
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2011)
Adverse events. [ Time Frame: 30 minutes after ]
30 minutes after the study drug administered
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Paracetamol, Dexketoprofen or Morphine for the Treatment of Low Back Pain
Official Title  ICMJE Pamukkale University Medical School,Dept. of Emergency Medicine
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.
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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: morphine
    Intervention: Drug: Paracetamole
  • Experimental: Paracetamole, dexketoprofen
    Paracetamole, dexketoprofen
    Interventions:
    • Drug: paracetamol
    • Drug: morphine
    • Drug: Dexketoprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2011)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01422291
Other Study ID Numbers  ICMJE serinken 002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mustafa Serinken, Pamukkale University
Study Sponsor  ICMJE Pamukkale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pamukkale University
Verification Date August 2011

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