NCT02749409

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2016

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 8, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
Last Updated

January 31, 2020

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

April 7, 2016

Last Update Submit

January 29, 2020

Conditions

ParecoxibRib Fractures

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    1 year

Study Arms (2)

Control group

ACTIVE COMPARATOR

The control group will be given Morphine prn after admission

Drug: Morphine

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

Drug: Parecoxib

Interventions

ParecoxibDRUG
Experimental group
MorphineDRUG
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rib Fractures

Interventions

parecoxibMorphine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 25, 2016

Study Start

August 8, 2016

Primary Completion

July 10, 2018

Study Completion

July 20, 2018

Last Updated

January 31, 2020

Record last verified: 2016-07