Dexketoprofen and Ibuprofen in Long Bone Fractures

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Recruiting

CT.gov ID

NCT06060236

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Bone Fracture	Drug: Ibuprofen 800 mg Drug: Dexketoprofen	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual analog scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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