- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02322463
Ethnicity and Analgesic Practice in a Pediatric Emergency Department
February 2, 2015 updated by: Rambam Health Care Campus
Early and appropriate pain management in the emergency department (ED) is an important aspect of child care.
Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures.
The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED.
The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture.
Study Overview
Detailed Description
Early and appropriate pain management in the emergency department (ED) is an important aspect of child care.
Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures.
The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED.
The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture .
Study Type
Observational
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Itai Shavit, MD
- Phone Number: +972502063239
- Email: itai@pem-database.org
Study Locations
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-
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Haifa, Israel
- Recruiting
- Rambam Health Care Campus
-
Contact:
- Itai Shavit, MD
- Phone Number: +972502063239
-
Principal Investigator:
- Itai Shavit, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients who were admitted to the pediatric ED due to a limb fracture between 01 January 2011 and 31 October 2014
Description
Inclusion Criteria:
-Any patient with a limb fracture
Exclusion Criteria:
- Multi trauma patients
- Patients with unidentified ethnicity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Arab children (case subjects)
Arab patients who were admitted to the pediatric ED due to a limb fracture between 01 January 2011 and 31 October 2014, who were treated with Oxycodone
|
Treatment with Oxycodone
Other Names:
|
Jewish children (controls)
Jewish patients who were admitted to the pediatric ED due to a limb fracture between 01 January 2011 and 31 October 2014, who were treated with Oxycodone
|
Treatment with Oxycodone
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of oxycodone treatment by the nursing staff
Time Frame: At triage up to 1 hour after admission at the recpetion desk
|
At triage up to 1 hour after admission at the recpetion desk
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ITAI Shavit, MD, Rambam Health Care Campus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
December 6, 2014
First Submitted That Met QC Criteria
December 17, 2014
First Posted (Estimate)
December 23, 2014
Study Record Updates
Last Update Posted (Estimate)
February 4, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0533-14-RMB-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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