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

NCT01514097 | Unknown

• 1 other identifier: 1112-120
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

emergency; pediatric; fracture; pain

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Numeric pain scale from 0 - 10. 10 indicating the worst pain

  day 2 - 3

Secondary Outcomes (1)

• Second pain score assessment

  7-8 days after ED discharge

Study Arms (2)

Fractures reduced

Fractures splinted

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric emergency department

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Twin Cities, Minnesota, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Emergencies; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 20, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 30, 2015

Record last verified: 2014-04

Locations

US (1)