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

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ClinicalTrials.gov Identifier: NCT02777320
Recruitment Status : Unknown
Verified July 2016 by Mustafa Serinken, Pamukkale University.
Recruitment status was:  Recruiting
First Posted : May 19, 2016
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Mustafa Serinken, Pamukkale University

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.


Condition or disease Intervention/treatment Phase
Sciatica Drug: paracetamol Drug: Ibuprofen Phase 4

Detailed Description:

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 pack was obtained, and administered as a infusion over 5 minutes.
  • Randomization was achieved by using computer software to generate random numbers.
  • One researcher blinded to patient allocation observed the whole procedure and recorded the Sciatica pain scores.
  • Patients in both groups received two types of medication in a similar manner (for example, 150 ml normal saline given as a slow intravenous infusion over 5 minutes), thus ensuring double blinding.
  • Sciatica pain scores were recorded at 0, 15, and 30 min on a VAS of 1 to 10
  • Rescue medication is given patients If the clinician think it's necessary within 30 minutes after study drug administration.
  • All other medications required during the study also were recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial.
Study Start Date : March 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica

Arm Intervention/treatment
Experimental: paracetamol group
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)
Drug: paracetamol
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)
Other Names:
  • Perfalgan
  • Partemol
  • Parol

Experimental: Ibuprofen group
Second Group: 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
Drug: Ibuprofen
400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
Other Names:
  • Intrafen
  • Caldolon




Primary Outcome Measures :
  1. 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


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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who presented with complaints of leg pain radiating the sciatic nerve tracings to the emergency services (Which may or may not be accompanied back pain),
  • Positive Laseque test identified patients in physical examination,
  • Patients whose complaints have started in the last week,
  • Younger than 21 years old,
  • Older than 65 years old.

Exclusion Criteria:

  • Patients who have a leg or low back pain longer than a week Have a direct blunt trauma to the legs or lumbar area in the last week,
  • Pretreatment linear 100-mm visual analog scale (VAS) pain score less than 40 mm,
  • Patients who have drop foot, paralysis and other neurological symptoms in physical examination.
  • Patients with blood pressure less than 90mmHg in the arrival of emergency services.
  • Patients with malignancy, cauda equina syndrome, ankylosing spondylitis, rheumatoid arthritis or inflammatory arthritis contain any of the disease in his/her CV.
  • Patients with any history of chronic pain syndrome.
  • Patients who receive pain killers, antidepressants, anticonvulsants, muscle relaxants, steroids within 6 hours before the ED visit,
  • Patients with a history of Substance Dependence or alcohol abuse
  • Patients had a fever (>37.9)
  • Allergy or previous adverse reaction to the studied drugs(Ibuprofen, Paracetamol), received agents to inhibit the secretion of acid (PPIs or histamine-2 receptor antagonists), antispasmodics, or nonsteroidal anti-inflammatory drugs
  • were pregnant or breast-feeding,
  • inability to comprehend the VAS evaluation,
  • or refused to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777320


Contacts
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Contact: Mustafa SERINKEN, professor +905052991497 aserinken@hotmail.com
Contact: Hayri ELICABUK, MD +905385079500 hayrielicabuk@hotmail.com

Locations
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Turkey
Pamukkale University Recruiting
Denizli, Turkey, 20070
Contact: Mustafa SERINKEN, Professor    +905052991497    aserinken@hotmail.com   
Contact: Hayri ELİÇABUK, MD    +905385079500    hayrielicabuk@hotmail.com   
Principal Investigator: Cenker Eken, associate professor         
Sponsors and Collaborators
Pamukkale University
Investigators
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Study Director: Mustafa SERINKEN, professor Pamukkale University
Study Director: Cenker EKEN, associate professor Akdeniz University

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Responsible Party: Mustafa Serinken, professor, Pamukkale University
ClinicalTrials.gov Identifier: NCT02777320     History of Changes
Other Study ID Numbers: Sciatica-IvsP
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mustafa Serinken, Pamukkale University:
Sciatica
Ibuprofen
Paracetamol
Emergency Medicine
Additional relevant MeSH terms:
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Ibuprofen
Sciatica
Emergencies
Disease Attributes
Pathologic Processes
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics