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

NCT02777320 | Unknown Phase 4 DMC

• 1 other identifier: Sciatica-IvsP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sciatica

Keywords

Sciatica; Ibuprofen; Paracetamol; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  30 minutes after the drug administered.

Study Arms (2)

paracetamol group

EXPERIMENTAL

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

Ibuprofen group

EXPERIMENTAL

Second Group: 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes

Drug: Ibuprofen

Interventions

paracetamol DRUG

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)

Also known as: Perfalgan, Partemol, Parol

paracetamol group

Ibuprofen DRUG

400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes

Also known as: Intrafen, Caldolon

Ibuprofen group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sciatica

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Mustafa SERINKEN, professor

  Pamukkale University

  STUDY DIRECTOR

• Cenker EKEN, associate professor

  Akdeniz University

  STUDY DIRECTOR

Central Study Contacts

Mustafa SERINKEN, professor

CONTACT

+905052991497; aserinken@hotmail.com

Hayri ELICABUK, MD

CONTACT

+905385079500; hayrielicabuk@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

TU (1)