Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain

February 8, 2018 updated by: Ibrahim Turkcuer, Pamukkale University

Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20070
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Paracetamol
1000 mg of paracetamol (perfalgan 10mg/ml solution Bristol-Myers Squibb_UK) intravenous (IV) was given 100 patients
Drug: Paracetamol
1000 mg of paracetamol (perfalgan 10mg/ml solutionBristol-Myers Squibb_UK) intravenous (IV) was given 100patients
Other Names:
  • Perfalgan
EXPERIMENTAL: Dexketoprofen
Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients
Drug: Dexketoprofen
Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients
Other Names:
  • ASEKET
  • DARKIN
  • DEXALGIN
  • DESTIYO
  • DEXCORIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrement of the pain on VAS
Time Frame: Baseline and 60 minutes
Comparison of the reduction of traumatic musculoskeletal pain VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Dexketoprofen)
Baseline and 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (ACTUAL)

February 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015HZL031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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