Clinical Trial: Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial.

Brief Summary:

Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for the pain treatments.

The objective of the study was to assess whether intravenous Paracetamol has superior Sciatica pain reduction will compare with Ibuprofen in emergency department (ED) adults.

Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.


Detailed Summary:

Paracetamol and Ibuprofen each relieve pain witf different mechanisms.

Paracetamol is termed a simple analgesic and an antipyretic. Despite enduring assertions that it acts by inhibition of cyclooxygenase (COX)-mediated production of prostaglandins, unlike non-steroidal anti-inflammatory drugs (NSAIDs).

Ibuprofen is the most commonly used and most frequently prescribed NSAID. It is a non-selective inhibitor of cyclo-oxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2).4 Although its anti inflammatory properties may be weaker than those of some other NSAIDs, it has a prominent analgesic and antipyretic role.

In our trial; The investigators aimed to compare intravenous Paracetamol and Ibuprofen in patient with Sciatica

  • All patients eligible for the study(Approximately 200 patient with sciatica) were randomized to one of two groups:
  • First Group: 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
  • 100 ml of saline is removed before the addition of the 100 ml paracetamol to be the same volume.
  • Second Group: 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
  • Drug packs were prepared according to the computer-generated random number sequence to assign treatment allocations
  • The allocation list was kept by the emergency nurse. Patients received the paracetamol or Ibuprofen medication schemes according to their random allocations.
  • After enrollment and recording of baseline information, the next numbered study drug
    Sponsor: Pamukkale University

    Current Primary Outcome: Reduction of Sciatica pain in Visual Analog Scale İn 30 minutes. [ Time Frame: Sciatica pain scores will be recorded at 0, 15, and 30 min. ]

    this work tooks 6 mounts


    Original Primary Outcome: The objective of the study was to assess whether intravenous Paracetamol has superior Sciatica pain reduction will compare with Ibuprofen in emergency department (ED) adults [ Time Frame: Sciatica pain scores will be recorded at 0, 15, and 30 min on a VAS of 1 to 10 ]

    this work tooks 6 mounts


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

    30 minutes after the study drug administered


    Original Secondary Outcome:

    Information By: Pamukkale University

    Dates:
    Date Received: May 17, 2016
    Date Started: March 2016
    Date Completion: September 2016
    Last Updated: July 14, 2016
    Last Verified: July 2016