Recruiting

Observational Study

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT01514097

Conditions

Fracture

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Study Details

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 ID

NCT01514097

Start date

Feb, 2012

Status verified date

Apr, 2014

Completion date

Jan, 2016

Anticipated

Primary completion date

Jan, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Fractures reduced

Fractures splinted

Primary outcome measure

  • Pain Score [ Time Frame: day 2 - 3 ]

Central Contacts and Locations

Locations

Children's Hospitals and Clinics of Minnesota

Recruiting

Twin Cities, Minnesota, United States

Contacts

Heidi Vander Velden, MS

612-813-7892

Principal Investigator:

Henry Ortega, MD

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Jul 30, 2015

Last verified

Apr, 2014

Keywords

  • emergency
  • pediatric
  • fracture
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2015-07-30.