Back to resultsDexketoprofen and Ibuprofen in Long Bone Fractures
Primary Purpose
Pain, Bone Fracture
Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ibuprofen 800 mg
Dexketoprofen
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Long bone fracture, ibuprofen, dexketoprofen, pain
Eligibility Criteria
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
Sites / Locations
- Ankara Bilkent Şehir HastanesiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ibuprofen
dexketoprofen
Arm Description
ibuprofen intravenous 800 mg
dexketoprofen intravenous 50 mg
Outcomes
Primary Outcome Measures
Visual analog scale
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06060236
First Posted
September 23, 2023
Last Updated
September 28, 2023
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT06060236
Brief Title
Dexketoprofen and Ibuprofen in Long Bone Fractures
Official Title
Comparison of Analgesic Efficacy of Dexketoprofen and Ibuprofen in Long Bone Fractures: Randomised Controlled Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Bone Fracture
Keywords
Long bone fracture, ibuprofen, dexketoprofen, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ibuprofen
Arm Type
Experimental
Arm Description
ibuprofen intravenous 800 mg
Arm Title
dexketoprofen
Arm Type
Experimental
Arm Description
dexketoprofen intravenous 50 mg
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 800 mg
Intervention Description
Ibuprofen 800 Mg İv
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Intervention Description
Dexketoprofen 50 Mg İV
Primary Outcome Measure Information:
Title
Visual analog scale
Description
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.
Time Frame
120 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Safa Dönmez, MD
Phone
+905537515545
Email
drsafa0131@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safa Dönmez, MD
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Bilkent Şehir Hastanesi
City
Ankara
ZIP/Postal Code
06170
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safa Dönmez
Email
drsafa0131@gmail.com
First Name & Middle Initial & Last Name & Degree
Safa Dönmez
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25349008
Citation
Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.
Results Reference
result
PubMed Identifier
19624576
Citation
Friday JH, Kanegaye JT, McCaslin I, Zheng A, Harley JR. Ibuprofen provides analgesia equivalent to acetaminophen-codeine in the treatment of acute pain in children with extremity injuries: a randomized clinical trial. Acad Emerg Med. 2009 Aug;16(8):711-6. doi: 10.1111/j.1553-2712.2009.00471.x. Epub 2009 Jul 14.
Results Reference
result
Learn more about this trial
Dexketoprofen and Ibuprofen in Long Bone Fractures
We'll reach out to this number within 24 hrs