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

Phase 3

Terminated

• Conditions: Parecoxib; Rib Fractures
• Interventions: Drug: Parecoxib; Drug: Morphine

• Registration Number: NCT02749409
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Status Verified: 2016-07
• Study Start: 2016-08-08
• Primary Completion: 2018-07-10
• Study Completion: 2018-07-20
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Parecoxib	the experimental group will be given parecoxib after admission by intravenous method every 12 hours for 4 days. Then Morphine agent will be given prn usage
Control group	Morphine	The control group will be given Morphine prn after admission

Primary Outcome Measures

Name	Time	Method
all cause mortality	1 year