Head Trauma Clinical Trial
Official title:
Is a Two-Film Skull X-ray Series as Sensitive as a Four-Film Series in the Diagnosis of Skull Fractures in Paediatric Patients With Minor Head Trauma?
Minor head injuries are a common presenting complaint in the pediatric emergency department. Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. However, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. This study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians.
Minor head injuries are a common presenting complaint in the pediatric emergency department.
Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of
minor head trauma. However, there exists ongoing controversy regarding the ideal number of
views that should be obtained in a skull series. This study aims to determine if there is a
significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of
fracture in paediatric minor head trauma patients when a 2-film series as opposed to a
4-film series is provided to participating pediatric emergency physicians.
This will be a prospective, crossover experimental study evaluating the equivalency in
sensitivity and specificity of a 2-film series versus a 4-film series in the diagnosis of
skull fracture associated with minor head injuries in children.
The study will involve 10 pediatric emergency physicians who will evaluate two modules of
100 series of radiography.
In order to do so, he or she will be given two work modules. Each module will contain the
randomized and anonymous x-rays of the same 50 cases and 50 controls mounted on power point
slides. Among the 50 cases, the evaluation sequence will be randomized such that 25 cases
will be evaluated with the 2-film series in the first module and the 4-film series in the
second module while the other 25 cases will evaluated in the reverse order. The same
procedure will be used for randomizing the evaluation sequence of the 50 controls.
The primary outcomes will be the overall sensitivity and specificity of pediatric emergency
medicine physicians for the detection of skull fractures using two evaluation methods: one
in which they are presented with a skull series that has 2 views and another in which they
are presented with a standard 4-view series.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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