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

NCT ID: NCT04609254

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2020-09-15

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

Detailed Description

• This is the randomized double blinded clinical trial to compare the efficacy of these three drugs in this clinical setting.
• A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital
• Study personnel (emergency physicians and nurses) were trained before the study.
• When intravenous drugs (Paracetamol, Dexketoprofen and ibuprofen) was being recommended, an eligibility checklist was completed by the attending physician.
• If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial Non-Traumatic Acute Low Back Pain severity ratings with visual analog scale (VAS) were recorded.
• The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
• All patients eligible for the study were randomized to one of three groups:

First Group: 1000 mg of paracetamol (parol 1000mg vial-atabay chemistry-İstanbul ) intravenous (IV) was given 71 patients, Second Group: dexketoprofen 50 mg ( arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, third group: 400 mg İbuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group. Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study.

• Drugs 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,dexketoprofen,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 intravenously.
• Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
• One researcher blinded to patient allocation observed the whole procedure and recorded the Non-Traumatic Acute Low Back Pain scores.
• Patients in three groups received three types of medication in a similar manner, thus ensuring double blind.

Non-Traumatic Acute Low Back Pain scores were recorded at 0, 15, 30 and 60 min on a VAS of 1 to 100

• During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.

Conditions

Low Back Pain, Mechanical

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

First Group

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

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: DRUG

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

Second Group

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

Group Type: EXPERIMENTAL

Dexketoprofen

Intervention Type: DRUG

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

Third group

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

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

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

Interventions

Paracetamol

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

Intervention Type: DRUG

Dexketoprofen

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

Intervention Type: DRUG

Ibuprofen

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

Intervention Type: DRUG

Other Intervention Names

Perfalgan; ASEKET; DARKIN; DEXALGIN; DESTIYO; DEXCORIL; İntrafen

Eligibility Criteria

Inclusion Criteria

• • Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger Isolated non traumatic musculoskeletal pain Patients who agree to work and receive the approval VAS (visual analog scale) score>5.

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Turkcuer

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cansu Dogan, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019TIPF007

Identifier Type: -

Identifier Source: org_study_id