NCT02322463

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

December 6, 2014

Last Update Submit

February 2, 2015

Conditions

Keywords

patients who were admitted to the pediatric ED

Outcome Measures

Primary Outcomes (1)

  • Rate of oxycodone treatment by the nursing staff

    At triage up to 1 hour after admission at the recpetion desk

Study Arms (2)

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

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

Drug: Arab children

Interventions

Treatment with Oxycodone

Also known as: Arabs
Arab children (case subjects)Jewish children (controls)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Any patient with a limb fracture

You may not qualify if:

  • Multi trauma patients
  • Patients with unidentified ethnicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • ITAI Shavit, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2014

First Posted

December 23, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations