Limb FractureNCT02322463
Ethnicity and Analgesic Practice in a Pediatric Emergency Department
An observational study of Limb Fracture, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Limb Fracture
- What is being tested?
- Arab children
- How many people
- 5,000 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients who were admitted to the pediatric ED due to a limb fracture between 01 January 2011 and 31 October 2014
Who may be able to join
- -Any patient with a limb fracture
Who cannot join
- Multi trauma patients
- Patients with unidentified ethnicity
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Itai Shavit, MD, +972502063239
Itai Shavit, MD
About this study
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.
Read the 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 .
- Conditions
- Limb Fracture
- Being tested
- Arab children
- Keywords
- patients who were admitted to the pediatric ED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arab childrenDrug
Also called Arabs
Treatment with Oxycodone
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Arab children | |
| 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 Receives: Drug: Arab children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of oxycodone treatment by the nursing staff
Measured: At triage up to 1 hour after admission at the recpetion desk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limb FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ITAI Shavit, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322463
- Sponsor's protocol ID
- 0533-14-RMB-CTIL
- Status last verified
- Feb 2015
- First submitted
- 6 Dec 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shavit I, Brumer E, Shavit D, Eidelman M, Steiner IP, Steinberg C. Emergency Department Pain Management in Pediatric Patients With Fracture or Dislocation in a Bi-Ethnic Population. Ann Emerg Med. 2016 Jan;67(1):9-14.e1. doi: 10.1016/j.annemergmed.2015.07.497. Epub 2015 Sep 3.
PubMed 26343348
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnicity and Analgesic Practice in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT02322463
- Acronym / sponsor ID
- 0533-14-RMB-CTIL
- Conditions
- Limb Fracture
- Keywords
- patients who were admitted to the pediatric ED
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arab children (case subjects) | – | Drug: Arab childrenArab 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 |
| Jewish children (controls) | – | Drug: Arab childrenJewish 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients who were admitted to the pediatric ED due to a limb fracture between 01 January 2011 and 31 October 2014
Key inclusion criteria (1 listed)
- -Any patient with a limb fracture
Key exclusion criteria (2 listed)
- Multi trauma patients
- Patients with unidentified ethnicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arab childrenAlso: ArabsTreatment with Oxycodone | Drug | Arab children (case subjects), Jewish children (controls) |
Primary outcome
Rate of oxycodone treatment by the nursing staff
Time frame: At triage up to 1 hour after admission at the recpetion desk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Derived from this study: PubMed 26343348Shavit I, Brumer E, Shavit D, Eidelman M, Steiner IP, Steinberg C. Emergency Department Pain Management in Pediatric Patients With Fracture or Dislocation in a Bi-Ethnic Population. Ann Emerg Med. 2016 Jan;67(1):9-14.e1. doi: 10.1016/j.annemergmed.2015.07.497. Epub 2015 Sep 3.
Related trials for Limb Fracture
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ITAI Shavit, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Fracture, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Itai Shavit, MD (+972502063239, itai@pem-database.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of oxycodone treatment by the nursing staff (time frame: At triage up to 1 hour after admission at the recpetion desk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.