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

Sponsor

Pamukkale University (Other)

Overall Status

Completed

CT.gov ID

NCT04609254

Collaborator

(none)

210

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain, Mechanical	Drug: Paracetamol Drug: Dexketoprofen Drug: Ibuprofen	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of The Effectiveness of Intravenous Paracetamol, Dexketoprofen and Ibuprofen In The Treatment of Non-Traumatic Acute Low Back Pain In The Emergency Department

Actual Study Start Date :

Dec 15, 2018

Actual Primary Completion Date :

Apr 15, 2020

Actual Study Completion Date :

Sep 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: First Group 1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,	Drug: Paracetamol 1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients, Other Names: Perfalgan
Experimental: Second Group dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,	Drug: Dexketoprofen dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, Other Names: ASEKET DARKIN DEXALGIN DESTIYO DEXCORIL
Experimental: 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.	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. Other Names: İntrafen

Arm

Intervention/Treatment

Experimental: First Group

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

Drug: Paracetamol

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

Other Names:

Perfalgan

Experimental: Second Group

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

Drug: Dexketoprofen

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

Other Names:

ASEKET

DARKIN

DEXALGIN

DESTIYO

DEXCORIL

Experimental: 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.

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.

Other Names:

İntrafen

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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