Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain
Primary Purpose
Musculoskeletal Pain
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
Dexketoprofen
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain focused on measuring paracetamol, dexketoprofen, emergency department, musculoskeletal pain
Eligibility Criteria
Inclusion Criteria:
- Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
- Isolated 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 sciatica and back pain
- Patients with cardiac chest pain
- Patients with chronic pain
- Patients with pre-existing dexketoprofen and paracetamol-induced gastrointestinal bleeding and perforation
- Patients with reflected pain
- Patients with neoplastic pain
- Patients with an allergy trait (paracetamol and dexketoprofen)
- Illiterates and patients with vision problems
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Paracetamol
Dexketoprofen
Arm Description
1000 mg of paracetamol (perfalgan 10mg/ml solution Bristol-Myers Squibb_UK) intravenous (IV) was given 100 patients
Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients
Outcomes
Primary Outcome Measures
Decrement of the pain on VAS
Comparison of the reduction of traumatic musculoskeletal pain VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Dexketoprofen)
Secondary Outcome Measures
Full Information
NCT ID
NCT03428503
First Posted
February 5, 2018
Last Updated
February 8, 2018
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT03428503
Brief Title
Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain
Official Title
Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Data Monitoring Committee
Yes
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 acute traumatic musculoskeletal pain.
The objective of the study is compare the efficacy of intravenous dexketoprofen with paracetamol in the treatment of acute traumatic musculoskeletal pain.
Detailed Description
This is the randomized double blinded clinical trial to compare the efficacy of these two 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) 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 acute traumatic musculoskeletal 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 two groups:
First Group: 1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol-Myers Squibb_UK) intravenous (IV) was given 100 patients, Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 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 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 acute non-traumatic musculoskeletal pain scores.
Patients in both groups received two types of medication in a similar manner, thus ensuring double blind.
Acute traumatic musculoskeletal pain scores were recorded at 0, 15, 30 and 60 min on a VAS of 1 to 10
Rescue medication (Fentanyl 1mcg/kg) was given intravenous to patients if pain VAS scores ≥ 5 in sixty minutes after study drug administration.
All other medications required during the study also were recorded.
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
Musculoskeletal Pain
Keywords
paracetamol, dexketoprofen, emergency department, musculoskeletal pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
1000 mg of paracetamol (perfalgan 10mg/ml solution Bristol-Myers Squibb_UK) intravenous (IV) was given 100 patients
Arm Title
Dexketoprofen
Arm Type
Experimental
Arm Description
Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
1000 mg of paracetamol (perfalgan 10mg/ml solutionBristol-Myers Squibb_UK) intravenous (IV) was given 100patients
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Other Intervention Name(s)
ASEKET, DARKIN, DEXALGIN, DESTIYO, DEXCORIL
Intervention Description
Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients
Primary Outcome Measure Information:
Title
Decrement of the pain on VAS
Description
Comparison of the reduction of traumatic musculoskeletal pain VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Dexketoprofen)
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 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 sciatica and back pain
Patients with cardiac chest pain
Patients with chronic pain
Patients with pre-existing dexketoprofen and paracetamol-induced gastrointestinal bleeding and perforation
Patients with reflected pain
Patients with neoplastic pain
Patients with an allergy trait (paracetamol and dexketoprofen)
Illiterates and patients with vision problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atakan Yilmaz, 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
Citations:
PubMed Identifier
30100336
Citation
Yilmaz A, Sabirli R, Ozen M, Turkcuer I, Erdur B, Arikan C, Demirozogul E, Sarohan A, Seyit M, Ok N. Intravenous paracetamol versus dexketoprofen in acute musculoskeletal trauma in the emergency department: A randomised clinical trial. Am J Emerg Med. 2019 May;37(5):902-908. doi: 10.1016/j.ajem.2018.08.023. Epub 2018 Aug 8.
Results Reference
derived
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Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain
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