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The goal of this intervention trial is to learn if a ultrasound diagnosis of elbow fractures can improve care in pediatric patients seen in the emergency room. The main questions it aims to answer are:
The primary outcomes measured are cost of the emergency visit, radiation exposure, time spent in the emergency department and patient satisfaction.
Patients who are evaluated with ultrasounds of the elbow will be compared to patients who have x-rays of the elbow.
Participants will be assigned either to the ultrasound group or x-rays group when they present with elbow pain.
The goal of this study is to evaluate whether the use of point-of-care ultrasonography (PoCUS) for elbow trauma evaluation results in less radiation exposure, less cost of treatment and shorter length of stay in Emergency Room (ER) than use of radiography. The study team will use PoCUS to screen for isolated elbow fractures presented to the ER. The researchers will compare cost of treatment both for patients and health care system and length of stay in both the groups. This study will also evaluate whether the use of PoCUS alleviates discomfort to pediatric patients and increases satisfaction of the families as compared to the use of radiography. Family satisfaction surveys and patient pain surveys will act as direct measures of family satisfaction. The study team will use length of stay and cost of treatment as indirect measures of satisfaction. The researchers will compare amount of comfort and satisfaction with and without the use of PoCUS to evaluate the overall patient comfortability and patient satisfaction. The researchers hypothesize that the use of PoCUS will reduce time of emergency department length of stay, radiation exposure, pain or discomfort and cost, and will increase patient's and family satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients elbow pain diagnosed with ultrasound | Experimental | Patients with elbow pain will receive an ultrasound of the elbow to evaluate for the present of an elbow fractures, hemarthrosis and/or lipohemarthrosis |
|
| Patient elbow pain diagnosed with x-ray | Active Comparator | Patients with elbow pain will review a standard two view elbow x-ray (anterior- posterior and lateral) to evaluate for a fracture around the elbow and/or hemarthrosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound of the elbow | Diagnostic Test | An ultrasound of the elbow obtained of pediatric patients with elbow pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | The patient satisfaction scores will be collected by the research assistant using the Emergency Department Consumer Assessment of Healthcare Providers and Systems Survey (ED CAHPS Survey) Version 1.0. The survey will be scored based on the recommended guidelines from CAHPS. Please see the attached scoring guidelines for further information. | Day 1 |
| cost of treatment | Cost of treatment: will be based from hospital charges in United States Dollars (USD). The cost will be based off the cash charge for the 3-4 view x-rays of the elbow. This information is readily available online and is currently $652.00 . It would be impossible to base from reimbursement as each insurance provider reimburses at a different rate. No cost will be assigned for the ultrasound as it is a point of care (POC) device that has no charge. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | calculated and recorded in EPIC. The time in minutes will be calculated from from the start when the patient is registered in the ED. All patients are registered and triaged when they enter the ED lobby. The time in ED in Epic is then stopped when the patient is discharged by the nurse. | Day1 |
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Inclusion Criteria:
• Pediatric patient with elbow pain
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Malone, DO | Contact | 407-319-3487 | jason.malone@nemours.org |
| Name | Affiliation | Role |
|---|---|---|
| Jason B Malone, DO | Nemours Children's Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Hospital | Recruiting | Orlando | Florida | 32827 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26752721 | Background | Thukral BB. Problems and preferences in pediatric imaging. Indian J Radiol Imaging. 2015 Oct-Dec;25(4):359-64. doi: 10.4103/0971-3026.169466. | |
| 19468873 | Background | Crowther M. Elbow pain in pediatrics. Curr Rev Musculoskelet Med. 2009 Jun;2(2):83-7. doi: 10.1007/s12178-009-9049-4. Epub 2009 Mar 14. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2025 |
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| X-ray of elbow | Diagnostic Test | An x-ray of the elbow obtained of pediatric patients with elbow pain |
|
| Pain During Imaging Procedure |
Patient pain scores who are younger than 3 years will be collected by using The FLACC score (for face, legs, activity, cry, concealability) The pain scores will be collected using the Wong-Baker FACES Pain Rating Scale for patients ages equal to and greater than 3 years old. |
| Day 1 |
| 12244457 | Background | Hall EJ. Lessons we have learned from our children: cancer risks from diagnostic radiology. Pediatr Radiol. 2002 Oct;32(10):700-6. doi: 10.1007/s00247-002-0774-8. Epub 2002 Jul 19. |
| 27645809 | Background | Avci M, Kozaci N, Beydilli I, Yilmaz F, Eden AO, Turhan S. The comparison of bedside point-of-care ultrasound and computed tomography in elbow injuries. Am J Emerg Med. 2016 Nov;34(11):2186-2190. doi: 10.1016/j.ajem.2016.08.054. Epub 2016 Aug 27. |
| 31080032 | Background | Lee SH, Yun SJ. Diagnostic Performance of Ultrasonography for Detection of Pediatric Elbow Fracture: A Meta-analysis. Ann Emerg Med. 2019 Oct;74(4):493-502. doi: 10.1016/j.annemergmed.2019.03.009. Epub 2019 May 9. |
| 18566177 | Background | Mettler FA Jr, Huda W, Yoshizumi TT, Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: a catalog. Radiology. 2008 Jul;248(1):254-63. doi: 10.1148/radiol.2481071451. |
| 27697406 | Background | Burnier M, Buisson G, Ricard A, Cunin V, Pracros JP, Chotel F. Diagnostic value of ultrasonography in elbow trauma in children: Prospective study of 34 cases. Orthop Traumatol Surg Res. 2016 Nov;102(7):839-843. doi: 10.1016/j.otsr.2016.07.009. Epub 2016 Sep 30. |
| 27278028 | Background | Eckert K, Ackermann O, Janssen N, Schweiger B, Radeloff E, Liedgens P. Accuracy of the sonographic fat pad sign for primary screening of pediatric elbow fractures: a preliminary study. J Med Ultrason (2001). 2014 Oct;41(4):473-80. doi: 10.1007/s10396-014-0525-0. Epub 2014 Mar 6. |
| 23142008 | Background | Rabiner JE, Khine H, Avner JR, Friedman LM, Tsung JW. Accuracy of point-of-care ultrasonography for diagnosis of elbow fractures in children. Ann Emerg Med. 2013 Jan;61(1):9-17. doi: 10.1016/j.annemergmed.2012.07.112. Epub 2012 Nov 9. |
| 17763294 | Background | Kraus R, Berthold LD, von Laer L. [Efficient imaging of elbow injuries in children and adolescents]. Klin Padiatr. 2007 Sep-Oct;219(5):282-7. doi: 10.1055/s-2007-970588. German. |
| Oct 20, 2025 |
| Prot_SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: Seven to Eleven Year old Assent | May 19, 2025 | Sep 30, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parental Permission | May 19, 2025 | Sep 30, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent | May 19, 2025 | Sep 30, 2025 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Children's Assent 12-17 years old | May 19, 2025 | Sep 30, 2025 | ICF_004.pdf |
| ID | Term |
|---|---|
| D000092467 | Radial Head and Neck Fractures |
| D006810 | Humeral Fractures |
| D000092482 | Elbow Fractures |
| D009011 | Monteggia's Fracture |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D011885 | Radius Fractures |
| D005543 | Forearm Injuries |
| D050723 | Fractures, Bone |
| D000072039 | Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014458 | Ulna Fractures |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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