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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sciatica
• Intervention / Treatment: Drug: paracetamol; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mustafa SERINKEN, Professor; Phone Number: +905052991497; Email: aserinken@hotmail.com
• Study Contact Backup: Name: Hayri ELİÇABUK, MD; Phone Number: +905385079500; Email: hayrielicabuk@hotmail.com

Study Locations

• Turkey
  • Denizli, Turkey, 20070
    • Recruiting
    • Pamukkale University
    • Contact: Mustafa SERINKEN, Professor; Phone Number: +905052991497; Email: aserinken@hotmail.com
    • Contact: Hayri ELİÇABUK, MD; Phone Number: +905385079500; Email: hayrielicabuk@hotmail.com
    • Principal Investigator: Cenker Eken, associate professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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; Parol; Partemol
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: Caldolon; Intrafen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Sciatica pain in Visual Analog Scale İn 30 minutes.	this work tooks 6 mounts	Sciatica pain scores will be recorded at 0, 15, and 30 min.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	30 minutes after the study drug administered	30 minutes after the drug administered.

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Study Director: Mustafa Serinken, Professor, Pamukkale University; Study Director: Cenker EKEN, associate professor, Akdeniz University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 19, 2016

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Sciatica; Emergency Medicine; Ibuprofen; Paracetamol
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease Attributes; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Emergencies; Sciatica; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: Sciatica-IvsP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided