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IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

Primary Purpose

Sciatica

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
morphine
Placebo
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica focused on measuring sciatalgia, emergency department, paracetamol, morphine

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pamukkale University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Paracetamol

morphine

placebo

Arm Description

1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion.

0.1 mg/kg morphine in 100 ml saline with a rapid infusion.

100 ml saline

Outcomes

Primary Outcome Measures

Visual Analogue Scale Score to measure pain reduction
Visual Analogue Scale Score at 30 minutes in order to measure pain reduction

Secondary Outcome Measures

Rescue drug need questionnaire
The rescue drug need will be recorded by asking the study patient at 30 minutes. yes/no
Adverse effects
Adverse effects occurred within the 30 minutes period

Full Information

First Posted
July 2, 2015
Last Updated
July 21, 2015
Sponsor
Akdeniz University
Collaborators
Pamukkale University, Antalya Training and Research Hospital, University of Gaziantep, Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT02504996
Brief Title
IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia
Official Title
IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia in Patients Presented With Sciatalgia to Emergency Department: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
Collaborators
Pamukkale University, Antalya Training and Research Hospital, University of Gaziantep, Ataturk University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica
Keywords
sciatalgia, emergency department, paracetamol, morphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion.
Arm Title
morphine
Arm Type
Active Comparator
Arm Description
0.1 mg/kg morphine in 100 ml saline with a rapid infusion.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
100 ml saline
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
1 g paracetamol via intravenous route in 100 ml normal saline
Intervention Type
Drug
Intervention Name(s)
morphine
Other Intervention Name(s)
Morfin
Intervention Description
0.1 mg/kg morphine via intravenous route in 100 ml normal saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous 100 ml normal saline
Primary Outcome Measure Information:
Title
Visual Analogue Scale Score to measure pain reduction
Description
Visual Analogue Scale Score at 30 minutes in order to measure pain reduction
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Rescue drug need questionnaire
Description
The rescue drug need will be recorded by asking the study patient at 30 minutes. yes/no
Time Frame
30 minutes
Title
Adverse effects
Description
Adverse effects occurred within the 30 minutes period
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cenker Eken, MD
Phone
00905321593948
Email
cenkereken@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Serinken, MD
Phone
00905052991497
Email
aserinken@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Serinken, MD
Organizational Affiliation
Pamukkale University
Official's Role
Study Chair
Facility Information:
Facility Name
Pamukkale University Hospital
City
Denizli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aysel Özkan
Phone
00902582961758
Email
karek@pau.edu.tr
First Name & Middle Initial & Last Name & Degree
Mustafa Serinken, MD

12. IPD Sharing Statement

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IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

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