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

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ClinicalTrials.gov Identifier: NCT02749409
Recruitment Status : Terminated (Case numbers not enough, however, the funding is over)
First Posted : April 25, 2016
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parecoxib Rib Fractures Drug: Parecoxib Drug: Morphine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture
Actual Study Start Date : August 8, 2016
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
The control group will be given Morphine prn after admission
Drug: Morphine
Experimental: Experimental group
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
Drug: Parecoxib



Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02749409    
Other Study ID Numbers: PARECOXIB RIB
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: July 2016
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries
Parecoxib
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents