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

Sciatica Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Sciatica

• NCT number: NCT02777320
• Study type: Interventional
• Source: Pamukkale University
• Contact: Mustafa SERINKEN, professor
• Phone: +905052991497
• Email: aserinken@hotmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2016
• Completion date: September 2016