Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain

NCT04609254 | Completed Phase 4

• 1 other identifier: 2019TIPF007
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

• Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Non-Traumatic Acute Low Back Pain
• The objective of the study is compare the efficacy of intravenous dexketoprofen,ibuprofen with paracetamol in the treatment of Non-Traumatic Acute Low Back Pain

Conditions

Low Back Pain, Mechanical

Keywords

paracetamol; dexketoprofen; ibuprofen; emergency department; low back pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Non-Traumatic Acute Low Back Pain on the Visual Analog Scale at 60 minutes

  Baseline and 60 minutes

Study Arms (3)

First Group

EXPERIMENTAL

1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,

Drug: Paracetamol

Second Group

EXPERIMENTAL

dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,

Drug: Dexketoprofen

Third group

EXPERIMENTAL

400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group.

Drug: Ibuprofen

Interventions

Paracetamol DRUG

1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,

Also known as: Perfalgan

First Group

Dexketoprofen DRUG

dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,

Also known as: ASEKET, DARKIN, DEXALGIN, DESTIYO, DEXCORIL

Second Group

Ibuprofen DRUG

400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group.

Also known as: İntrafen

Third group

Eligibility Criteria

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

You may not qualify if:

• Patients with severe liver, kidney,pulmonary and cardiac heartfailure
• To be Pregnancy and breast-feeding
• Have received analgesics in the last 6hours
• Patients of childbearing age who are not using a birth control method.
• Patients with neurological deficits
• Patients with cardiac chest pain
• Patients with chronic pain
• Patients with pre-existing ibuprofen, dexketoprofen and paracetamolinduced gastrointestinal bleeding and perforation
• Patients with reflected pain
• Patients with neoplastic pain
• Patients with an allergy trait (ibuprofen, paracetamol and dexketoprofen)
• Illiterates and patients with vision problems

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Emergencies

Interventions

Acetaminophen; dexketoprofen trometamol; Ibuprofen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Cansu Dogan, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

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, MD

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: December 15, 2018
• Primary Completion: April 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)