The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound of the elbow, X-ray of elbow.
- Who it may be relevant to
- Registry conditions: Elbow Pain, Supracondylar Humerus Fracture, Radial Head Fractures, Radial Head or Neck Fractures. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures: Evaluation of Cost Savings, Radiation Exposure, and Patient Satisfaction
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Ultrasound of the elbow
An ultrasound of the elbow obtained of pediatric patients with elbow pain - Diagnostic test X-ray of elbow
An x-ray of the elbow obtained of pediatric patients with elbow pain
Primary outcome measures
- Patient Satisfaction [Time frame: Day 1]
- cost of treatment [Time frame: Day 1]
Secondary outcome measures (2)
- Length of Stay [Time frame: Day1]
- Pain During Imaging Procedure [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Pediatric patient with elbow pain
Exclusion criteria
- Polytrauma (more than one injury)
- Deformity of the arm including the elbow
- Pain in any other location than the elbow
- Pain in other parts of the same limb including the, wrist, forearm, shoulder, hand
- Pain in other limbs,
- Puckering of the skin (skin indentation)
- Obvious fracture
- Open wound at or around the elbow
- Pain and swelling without trauma
- Concerns for tumor or infection
- Suspected nursemaid's elbow
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Nemours Children's Hospital — Orlando
Publications
- 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. PMID 26752721
- 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. PMID 19468873
- 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. PMID 12244457
- 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. PMID 27645809
- 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. PMID 31080032
- 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. PMID 18566177
- 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. PMID 27697406
- 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. PMID 27278028
Identifiers
NCT: NCT07212036 · 2051060