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IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

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ClinicalTrials.gov Identifier: NCT02504996
Recruitment Status : Unknown
Verified July 2015 by Cenker Eken, Akdeniz University.
Recruitment status was:  Recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Collaborators:
Pamukkale University
Antalya Training and Research Hospital
University of Gaziantep
Ataturk University
Information provided by (Responsible Party):
Cenker Eken, Akdeniz University

Brief Summary:
Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. This study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.

Condition or disease Intervention/treatment Phase
Sciatica Drug: Paracetamol Drug: morphine Drug: Placebo Phase 4

Detailed Description:
Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. Neuronal compression is the main cause of pain in sciatalgia rather than inflammation which also differ sciatalgia from the other type of pains in emergency department. Sciatalgia is a kind of neuralgia and there is not so much option in the pain management of these patients. Intravenous paracetamol and morphine is commonly used analgesics in various kind of pain in emergency department. So, this study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia in Patients Presented With Sciatalgia to Emergency Department: A Randomized Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica

Arm Intervention/treatment
Active Comparator: Paracetamol
1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion.
Drug: Paracetamol
1 g paracetamol via intravenous route in 100 ml normal saline
Other Name: Perfalgan

Active Comparator: morphine
0.1 mg/kg morphine in 100 ml saline with a rapid infusion.
Drug: morphine
0.1 mg/kg morphine via intravenous route in 100 ml normal saline
Other Name: Morfin

Placebo Comparator: placebo
100 ml saline
Drug: Placebo
Intravenous 100 ml normal saline




Primary Outcome Measures :
  1. Visual Analogue Scale Score to measure pain reduction [ Time Frame: 30 minutes ]
    Visual Analogue Scale Score at 30 minutes in order to measure pain reduction


Secondary Outcome Measures :
  1. Rescue drug need questionnaire [ Time Frame: 30 minutes ]
    The rescue drug need will be recorded by asking the study patient at 30 minutes. yes/no

  2. Adverse effects [ Time Frame: 30 minutes ]
    Adverse effects occurred within the 30 minutes period



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 with pain radiating to the sciatic nerve path
  • Pain within the last one week
  • Patients with positive straight leg raise
  • Patients over 21 and lower than 65 years old

Exclusion Criteria:

  • Pain score lower than 40 mm in visual analogue scale score
  • Neurological deficit
  • Allergy to the study drugs
  • Unstable vital signs
  • History of malignancy or rheumatological diseases or arthritis
  • History of chronic pain syndrome
  • Receiving pain killer, steroid, anti-depressant, anti-convulsant and musculorelaxant within the last six hours.
  • Drug or alcohol addiction
  • Pregnancy or breast feeding
  • Fewer more than 37.9 Celsius degrees.

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): NCT02504996


Contacts
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Contact: Cenker Eken, MD 00905321593948 cenkereken@gmail.com
Contact: Mustafa Serinken, MD 00905052991497 aserinken@hotmail.com

Locations
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Turkey
Pamukkale University Hospital Recruiting
Denizli, Turkey
Contact: Aysel Özkan    00902582961758    karek@pau.edu.tr   
Principal Investigator: Mustafa Serinken, MD         
Sponsors and Collaborators
Akdeniz University
Pamukkale University
Antalya Training and Research Hospital
University of Gaziantep
Ataturk University
Investigators
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Study Chair: Mustafa Serinken, MD Pamukkale University

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Responsible Party: Cenker Eken, Associate Proffesor, Akdeniz University
ClinicalTrials.gov Identifier: NCT02504996     History of Changes
Other Study ID Numbers: 70178
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Keywords provided by Cenker Eken, Akdeniz University:
sciatalgia
emergency department
paracetamol
morphine
Additional relevant MeSH terms:
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Sciatica
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics