Dexketoprofen and Ibuprofen in Long Bone Fractures

September 28, 2023 updated by: Safa Dönmez, Ankara City Hospital Bilkent

Comparison of Analgesic Efficacy of Dexketoprofen and Ibuprofen in Long Bone Fractures: Randomised Controlled Double-blind Study

The aim of this study was to compare the efficacy of ibuprofen and dexketoprofen, two common analgesic drugs used in pain control in patients with long bone fractures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Long bone fractures are the fractures of long bones (tibia, femur, humerus) in the human body. Such fractures usually occur as a result of trauma and are manifested by symptoms such as pain, swelling, bruising and limitation of movement. Effective control of pain can help the patient relax and facilitate the healing process. Ibuprofen and dexketoprofen, which belong to the class of non-steroidal anti-inflammatory drugs (NSAID), are among the analgesics commonly used in the pain management of all fractures. These drugs are thought to be able to relieve pain, reduce inflammation, and help patients move. However, each patient's individual response and tolerance may differ, so the efficacy and side effects of each drug may vary from patient to patient. This makes it difficult to determine which analgesic is more effective and safe in clinical practice. The fact that it is a subject that has not been done much in the literature has led us to do this study.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06170
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi
        • Contact:
        • Principal Investigator:
          • Safa Dönmez

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • over 18 years
  • Patients under 80 years of age
  • Patients who agreed to participate in the study
  • One of the tibia, femur and humerus bones is broken
  • Patients with a VAS score of 50 and above
  • Patients with no other injuries requiring emergency surgery
  • Previously known adverse reactions to the active ingredient of the drugs to be used patients with no history
  • Conscious patients
  • Oriented cooperative patients

Exclusion Criteria:

  • Patients under the age of 18 and over the age of 80
  • Patients who did not agree to participate in the study
  • Patients with vital signs outside the normal limits
  • Patients with a history of adverse reactions to known NSAIDs
  • Those who cannot determine the severity of pain on the VAS
  • Patients with a VAS Score of 50 mm or less
  • Those with other orthopedic injuries pregnant women
  • Those with advanced systemic disease
  • Those with malignancy
  • Those with chronic liver and kidney disease
  • Those who use neuro-psychiatric drugs with sedative and analgesic effects
  • Those with a history of psychological and neurological diseases
  • Patients using analgesics 8 hours before the examination

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ibuprofen
ibuprofen intravenous 800 mg
Drug: Ibuprofen 800 mg
Ibuprofen 800 Mg İv
Experimental: dexketoprofen
dexketoprofen intravenous 50 mg
Drug: Dexketoprofen
Dexketoprofen 50 Mg İV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: 120 minute
The pain is determined using a 100 mm scale. Patients are instructed to mark the level of pain they experience, with 0 mm indicating no pain and 100 mm indicating the presence of maximum pain.
120 minute

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Safa Dönmez, MD, Ankara City Hospital Bilkent

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)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 23, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-23-4743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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