Dexketoprofen and Ibuprofen in Long Bone Fractures | NCT06060236

Studies
Dexketoprofen and Ibuprofen in Long Bone Fractures

NCT06060236

Sponsor

Ankara City Hospital Bilkent

Status

Unknown status

Last Update Posted

Oct 2, 2023Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Pain
Bone Fracture

Interventions

Ibuprofen 800 mg
Dexketoprofen

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Sep 1, 2024Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Sep 23, 2023

First Submission Date that Met QC Criteria

Sep 28, 2023

First Posted Date

Sep 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2023

Last Update Posted Date

Oct 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ibuprofen	Experimental	ibuprofen intravenous 800 mg	Drug: Ibuprofen 800 mg
dexketoprofen	Experimental	dexketoprofen intravenous 50 mg	Drug: Dexketoprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen 800 mg	Drug	Ibuprofen 800 Mg İv	ibuprofen
Dexketoprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	120 minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Safa Dönmez, MD	Contact	+905537515545		drsafa0131@gmail.com

Overall Officials

Name	Affiliation	Role
Safa Dönmez, MD	Ankara City Hospital Bilkent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara Bilkent Şehir Hastanesi	Recruiting	Ankara		06170	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25349008	Result	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.
19624576	Result

ID	Term
D010146	Pain
D050723	Fractures, Bone

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D014947	Wounds and Injuries

ID	Term
D007052	Ibuprofen
C118296	dexketoprofen trometamol

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals