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

NCT ID: NCT01514097

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

Fracture

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Fractures reduced

No interventions assigned to this group

Fractures splinted

No interventions assigned to this group

Eligibility 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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospitals and Clinics of Minnesota

Twin Cities, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Heidi Vander Velden, MS

Role: primary

612-813-7892

Other Identifiers

1112-120

Identifier Type: -

Identifier Source: org_study_id