Dexketoprofen and Ibuprofen in Long Bone Fractures

NCT ID: NCT06060236

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Pain Bone Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ibuprofen

ibuprofen intravenous 800 mg

Group Type EXPERIMENTAL

Ibuprofen 800 mg

Intervention Type DRUG

Ibuprofen 800 Mg İv

dexketoprofen

dexketoprofen intravenous 50 mg

Group Type EXPERIMENTAL

Dexketoprofen

Intervention Type DRUG

Dexketoprofen 50 Mg İV

Interventions

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Ibuprofen 800 mg

Ibuprofen 800 Mg İv

Intervention Type DRUG

Dexketoprofen

Dexketoprofen 50 Mg İV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Safa Dönmez

Department of Emergency Medicine, M.D. Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Safa Dönmez, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara Bilkent Şehir Hastanesi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Safa Dönmez, MD

Role: CONTACT

+905537515545

Facility Contacts

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Safa Dönmez

Role: primary

References

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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.

Reference Type RESULT
PMID: 25349008 (View on PubMed)

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.

Reference Type RESULT
PMID: 19624576 (View on PubMed)

Other Identifiers

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E2-23-4743

Identifier Type: -

Identifier Source: org_study_id

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