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

Fracture Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01514097
• Other study ID #: 1112-120
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2012
• Last updated: July 29, 2015
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: April 2014
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Twin Cities	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Numeric pain scale from 0 - 10. 10 indicating the worst pain	day 2 - 3	No
Secondary	Second pain score assessment	Numeric pain scale from 0 - 10. 10 indicating the worst pain	7-8 days after ED discharge	No