Clinical Trial: Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Nontraumatic Musculoskeletal Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Nontraumatic Musculoskeletal Pain in the Emergency Department: A Double-Blinded, Randomized,

Brief Summary:

  • Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with acute non traumatic musculoskeletal pain.
  • The objective of the study is compare the efficacy of intravenous dexketoprofen with paracetamol in the treatment of acute non-traumatic musculoskeletal pain.

Detailed Summary:

  • This is the randomized double blinded clinical trial to compare the efficacy of these two drugs in this clinical setting.
  • A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital
  • Study personnel (emergency physicians and nurses) were trained before the study.
  • When intravenous drugs (Paracetamol, Dexketoprofen) was being recommended, an eligibility checklist was completed by the attending physician.
  • If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial acute non-traumatic musculoskeletal pain severity ratings with visual analog scale (VAS) were recorded.
  • The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
  • All patients eligible for the study were randomized to one of two groups:

First Group: 1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol-Myers Squibb_UK) intravenous (IV) was given 100 patients, Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients which determined to be applied as a group.

Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study.

  • Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations
  • The allocation list was kept by the emergency nurse
    Sponsor: Pamukkale University

    Current Primary Outcome: Decrement of the pain on VAS [ Time Frame: Baseline and 60 minutes ]

    Comparison of the reduction of non-traumatic musculoskeletal pain VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Dexketoprofen)


    Original Primary Outcome: Decrement of the pain on VAS [ Time Frame: Change from Baseline in acute non-traumatic musculoskeletal pain VAS scores at 60 minutes. ]

    Comparison of the reduction of non-traumatic musculoskeletal pain VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Dexketoprofen)


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Pamukkale University

    Dates:
    Date Received: April 18, 2017
    Date Started: August 2015
    Date Completion:
    Last Updated: April 20, 2017
    Last Verified: April 2017