Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department

NCT02836509 | Unknown Phase 4 DMC

• 1 other identifier: LBPainIvsP
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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 Low Back 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

Low Back Pain

Keywords

Low Back Pain; Ibuprofen; Paracetamol; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Reduction of Low Back Pain on the Visual Analog Scale

  Low Back Pain scores will be recorded at 0, 15, and 30 min on a VAS of 1 to 10

Secondary Outcomes (1)

• Adverse events

  30th minutes after the study 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: 800 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.

Also known as: PERFALGAN, PARTEMOL, PAROL

paracetamol group

Ibuprofen DRUG

800 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 - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who presented with complaints of low back pain to the emergency services ,
• Patients whose complaints have started in the last week,
• Younger than 21 years old,
• older than 80 years old,

You may not qualify if:

• 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 have a history of active peptic ulcer disease,
• Patients who have signs of peritoneal irritation,
• 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

MeSH Terms

Conditions

Low Back Pain

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Back Pain; 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

Central Study Contacts

Mustafa SERINKEN, professor

CONTACT

505 2991497; aserinken@hotmail.com

hayri eliçabuk, medical Doctor

CONTACT

5385079500; 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: July 1, 2016
• First Posted: July 19, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 19, 2016

Record last verified: 2016-07