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临床试验/NCT02749409
NCT02749409终止3 期

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

Chang Gung Memorial Hospital0 个研究点目标入组 17 人开始时间: 2016年8月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
17
主要终点
all cause mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Investigators will prospective enroll patients who are diagnosed chest trauma with rib fractures
  • Age ≧18 y/o

排除标准

  • Patients who have history of heart failure, CAD history.
  • Traumatic cardiac injury and cardiac tamponade
  • History of allergy effect for Cyclooxygenase 2 (COX2) inhibitor or NSAID

研究组 & 干预措施

Control group

Active Comparator

The control group will be given Morphine prn after admission

干预措施: Morphine (Drug)

Experimental group

Experimental

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

干预措施: Parecoxib (Drug)

结局指标

主要结局

all cause mortality

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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