Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain
Primary Purpose
Low Back Pain, Mechanical
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
Dexketoprofen
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring paracetamol, dexketoprofen, ibuprofen, emergency department, low back pain
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
First Group
Second Group
Third group
Arm Description
1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,
dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,
400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group.
Outcomes
Primary Outcome Measures
Change From Baseline in Non-Traumatic Acute Low Back Pain on the Visual Analog Scale at 60 minutes
Secondary Outcome Measures
Full Information
NCT ID
NCT04609254
First Posted
October 26, 2020
Last Updated
October 29, 2020
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT04609254
Brief Title
Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
paracetamol, dexketoprofen, ibuprofen, emergency department, low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Group
Arm Type
Experimental
Arm Description
1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,
Arm Title
Second Group
Arm Type
Experimental
Arm Description
dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,
Arm Title
Third group
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Other Intervention Name(s)
ASEKET, DARKIN, DEXALGIN, DESTIYO, DEXCORIL
Intervention Description
dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
İntrafen
Intervention Description
400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group.
Primary Outcome Measure Information:
Title
Change From Baseline in Non-Traumatic Acute Low Back Pain on the Visual Analog Scale at 60 minutes
Time Frame
Baseline and 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cansu Dogan, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will be made available to other researchers whenever they need it.
Learn more about this trial
Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain
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