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

Primary Purpose

Parecoxib, Rib Fractures

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Parecoxib
Morphine
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parecoxib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Experimental group

    Arm Description

    The control group will be given Morphine prn after admission

    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

    Outcomes

    Primary Outcome Measures

    all cause mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2016
    Last Updated
    January 29, 2020
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02749409
    Brief Title
    Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture
    Official Title
    Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    Case numbers not enough, however, the funding is over
    Study Start Date
    August 8, 2016 (Actual)
    Primary Completion Date
    July 10, 2018 (Actual)
    Study Completion Date
    July 20, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parecoxib, Rib Fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The control group will be given Morphine prn after admission
    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Parecoxib
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Primary Outcome Measure Information:
    Title
    all cause mortality
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Investigators will prospective enroll patients who are diagnosed chest trauma with rib fractures Age ≧18 y/o Exclusion Criteria: 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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