FractureNCT01514097
Adequacy of Pain Management for Upper Extremity Fracture After Discharge From a Pediatric Emergency Depart
An observational study of Fracture, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Fracture
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric emergency department
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospitals and Clinics of Minnesota
Twin Cities, Minnesota
Heidi Vander Velden, MS, 612-813-7892
Henry Ortega, MD
About this study
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:
Read more
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
- Medical subject headings
- Fractures, Bone, Emergencies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fractures reduced | Not described | |
| Fractures splinted | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Numeric pain scale from 0 - 10. 10 indicating the worst pain
Measured: day 2 - 3
Secondary outcomes (1)
Second pain score assessment
Numeric pain scale from 0 - 10. 10 indicating the worst pain
Measured: 7-8 days after ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514097
- Sponsor's protocol ID
- 1112-120
- Status last verified
- Apr 2014
- First submitted
- 12 Jan 2012
- Last updated
- 30 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of Pain Management for Upper Extremity Fracture After Discharge From a Pediatric Emergency Depart
- ClinicalTrials.gov ID
- NCT01514097
- Acronym / sponsor ID
- 1112-120
- Conditions
- Fracture
- Keywords
- emergency, pediatric, fracture, pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractures reduced | – | – |
| Fractures splinted | – | – |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric emergency department
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Score
Time frame: day 2 - 3
Numeric pain scale from 0 - 10. 10 indicating the worst pain
1 secondary outcome
Second pain score assessment
Time frame: 7-8 days after ED discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: day 2 - 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.