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

Primary Purpose

Sciatica

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
paracetamol
Ibuprofen
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica focused on measuring Sciatica, Ibuprofen, Paracetamol, Emergency Medicine

Eligibility Criteria

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

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

Sites / Locations

  • Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

paracetamol group

Ibuprofen group

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction of Sciatica pain in Visual Analog Scale İn 30 minutes.
this work tooks 6 mounts

Secondary Outcome Measures

Adverse events
30 minutes after the study drug administered

Full Information

First Posted
May 17, 2016
Last Updated
July 14, 2016
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT02777320
Brief Title
Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department
Official Title
Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial.
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica
Keywords
Sciatica, Ibuprofen, Paracetamol, Emergency Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
paracetamol group
Arm Type
Experimental
Arm Description
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)
Arm Title
Ibuprofen group
Arm Type
Experimental
Arm Description
Second Group: 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Perfalgan, Partemol, Parol
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Intrafen, Caldolon
Intervention Description
400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
Primary Outcome Measure Information:
Title
Reduction of Sciatica pain in Visual Analog Scale İn 30 minutes.
Description
this work tooks 6 mounts
Time Frame
Sciatica pain scores will be recorded at 0, 15, and 30 min.
Secondary Outcome Measure Information:
Title
Adverse events
Description
30 minutes after the study drug administered
Time Frame
30 minutes after the drug administered.

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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa SERINKEN, professor
Phone
+905052991497
Email
aserinken@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hayri ELICABUK, MD
Phone
+905385079500
Email
hayrielicabuk@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa SERINKEN, professor
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cenker EKEN, associate professor
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa SERINKEN, Professor
Phone
+905052991497
Email
aserinken@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hayri ELİÇABUK, MD
Phone
+905385079500
Email
hayrielicabuk@hotmail.com
First Name & Middle Initial & Last Name & Degree
Cenker Eken, associate professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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