Dexketoprofen and Ibuprofen in Long Bone Fractures

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060236
• Other study ID #: E2-23-4743
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: Ankara City Hospital Bilkent
• Contact: Safa Dönmez, MD
• Phone: +905537515545
• Email: drsafa0131[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone
• Pain

Intervention

Drug:
• Ibuprofen 800 mg
Ibuprofen 800 Mg Iv
• Dexketoprofen
Dexketoprofen 50 Mg IV

Locations

Country	Name	City	State
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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