Pediatric radiology · 2012
Application of a second-generation US contrast agent in infants and children--a European questionnaire-based survey.
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Riccabona Michael
Аннотация
BACKGROUND: No US contrast agent (US-CA) is currently licensed for use in children.
OBJECTIVE: To survey the off-label use in children of a second-generation US-CA.
MATERIALS AND METHODS: Questionnaires were e-mailed to European paediatric radiologists, who were asked about their experience with the second-generation US-CA Sonovue® (Bracco, Milan, Italy). Number of examinations per indication and adverse effects were recorded. Examinations were categorised by intravenous or intracavitary use of US-CA.
RESULTS: Out of 146 respondents, 88 stated that they did not perform contrast-enhanced US in children, but 36 of these (44%) would appreciate paediatric approval. Forty-five centres reported 5,079 examinations in children (age mean: 2.9 years; range: birth-18 years, M/F: 1/ 2.8). The majority (4,131 [81%] in 29 centres) were intravesical applications. The minority (948 [19%] in 30 centres) were intravenous applications. No adverse effects had been recorded from intravesical use. Six minor adverse effects (skin reaction, unusual taste, hyperventilation) had been recorded after five intravenous studies (0.52%).
CONCLUSION: Responses suggest a favourable safety profile of this second-generation US-CA in children. It also demonstrates a demand for such US-CA from paediatric radiologists.
OBJECTIVE: To survey the off-label use in children of a second-generation US-CA.
MATERIALS AND METHODS: Questionnaires were e-mailed to European paediatric radiologists, who were asked about their experience with the second-generation US-CA Sonovue® (Bracco, Milan, Italy). Number of examinations per indication and adverse effects were recorded. Examinations were categorised by intravenous or intracavitary use of US-CA.
RESULTS: Out of 146 respondents, 88 stated that they did not perform contrast-enhanced US in children, but 36 of these (44%) would appreciate paediatric approval. Forty-five centres reported 5,079 examinations in children (age mean: 2.9 years; range: birth-18 years, M/F: 1/ 2.8). The majority (4,131 [81%] in 29 centres) were intravesical applications. The minority (948 [19%] in 30 centres) were intravenous applications. No adverse effects had been recorded from intravesical use. Six minor adverse effects (skin reaction, unusual taste, hyperventilation) had been recorded after five intravenous studies (0.52%).
CONCLUSION: Responses suggest a favourable safety profile of this second-generation US-CA in children. It also demonstrates a demand for such US-CA from paediatric radiologists.