Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture

Rib Fractures Clinical Trial

Official title:

Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02749409
• Other study ID #: PARECOXIB RIB
• Status: Terminated
• Phase: Phase 3
• Start date: August 8, 2016
• Est. completion date: July 20, 2018

Study information

• Verified date: July 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients diagnosed traumatic rib fracture and need admission will be included. Patients will be divided two groups.The experimental group will be given parecoxib after visiting emergency department. The control group will be given Narcotic agent such as morphine for pain control. The outcome such as numerical rating scale (NRS) and hospital length of stay will be recorded.

Description:

3.1 Inclusion/exclusion criteria Patients who are diagnosed ribs fracture and need admission. Exclusion criteria included heart failure, Coronary artery disease (CAD) history. Traumatic cardiac injury and cardiac tamponade will be excluded, too.

3.2 Group design Patients will be divided two groups, and the experimental group will be given parecoxib after visiting emergency department. And they will be kept given after admission by intravenous method every 12 hours for 4 days. The control group will be given Narcotic agent such as morphine for pain control. The daily dose will be recorded. Finally the end outcome will be recorded.

3.3 Data collection The data of patient's medical history and laboratory results will be recorded on pre-designed case report forms (CRFs) by study nurses. In all patients, age, gender, diagnosis, co-morbidities, length of hospital and intensive care unit (ICU) stay, Injury Severity Score (ISS) score, numerical rating scale (NRS) and outcomes, will be recorded. In addition, all microorganisms isolated and antibiotic substances applied will be documented.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: July 20, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Investigators will prospective enroll patients who are diagnosed chest trauma with rib fractures

2. Age ?18 y/o

Exclusion Criteria:

1. Patients who have history of heart failure, CAD history.

2. Traumatic cardiac injury and cardiac tamponade

3. History of allergy effect for Cyclooxygenase 2 (COX2) inhibitor or NSAID

Related Conditions & MeSH terms

• Fractures, Bone
• Parecoxib
• Rib Fractures

Intervention

Drug:
• Parecoxib

• Morphine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		1 year