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Adequacy of Pain Management for Upper Extremity Fracture After Discharge From a Pediatric Emergency Depart

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Children's Hospitals and Clinics of Minnesota.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01514097
First received: January 12, 2012
Last updated: July 29, 2015
Last verified: April 2014
  Purpose

Pain is a common cause for children seeking care in the Emergency Department (ED). Children with orthopedic injuries often require pain control when seeking emergency care. Despite the high prevalence of ED visits requiring pain control, pain is often poorly assessed and treated in ED settings. Currently, no standard of care exists for the management of this fracture-related pain in children discharged from the ED. Furthermore, discrepancies in analgesia administration to patients of various racial groups seeking emergency care have been documented but are poorly understood. No research currently exists comparing pain severity between upper extremity fractures requiring simple splinting to those treated with sedated reduction and splinting. Furthermore, there is no research regarding the prevalence of significant post-discharge pain nor the differences among ethnic and age groups treated in the ED.

Research Questions:

What is the prevalence of significant post-discharge pain in children treated for upper extremity fractures?

Is there a difference in severity between those children requiring reduction versus simple splinting?

Is there a difference in pain severity noted among different ethnic or age groups?

Design This is a prospective, un-blinded, observational study that will include patients seeking treatment for an upper extremity fracture.


Condition
Fracture

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Pain Score [ Time Frame: day 2 - 3 ]
    Numeric pain scale from 0 - 10. 10 indicating the worst pain


Secondary Outcome Measures:
  • Second pain score assessment [ Time Frame: 7-8 days after ED discharge ]
    Numeric pain scale from 0 - 10. 10 indicating the worst pain


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fractures reduced
Fractures splinted

  Eligibility

Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric emergency department
Criteria

Inclusion Criteria:

  • Parents/guardians of patients presenting to the ED will be included if:
  • The patient is younger than 18 years old
  • The patient has an isolated upper extremity fracture (including clavicle, humerus, forearm, wrist) undergoing ED splinting with or without reduction
  • The parent/guardian is English, Spanish, Somali, or Hmong-speaking
  • The parent/guardian lives with the child
  • He/she has a working telephone number

Exclusion Criteria:

  • Potential subjects presenting to the ED will be excluded from study participation if:
  • There is suspicion of child abuse or neglect
  • The parent/guardian is not English, Spanish, Somali, or Hmong-speaking
  • The patient is critically ill
  • The fracture requires operative reduction/treatment
  • The patient is medically complex
  • The patient has a pre-existing bone disease or chronic pain syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514097

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Recruiting
Twin Cities, Minnesota, United States
Contact: Heidi Vander Velden, MS    612-813-7892      
Principal Investigator: Henry Ortega, MD         
Sub-Investigator: Sam Reid, MD         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
  More Information

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01514097     History of Changes
Other Study ID Numbers: 1112-120
Study First Received: January 12, 2012
Last Updated: July 29, 2015

Keywords provided by Children's Hospitals and Clinics of Minnesota:
emergency
pediatric
fracture
pain

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 25, 2017