Published online Feb 8, 2017. doi: 10.5409/wjcp.v6.i1.52
Peer-review started: June 13, 2016
First decision: July 4, 2016
Revised: October 26, 2016
Accepted: November 16, 2016
Article in press: November 17, 2016
Published online: February 8, 2017
Processing time: 235 Days and 10.7 Hours
To evaluate the risk profile of sulfur hexafluoride in voiding urosonography (VUS) based on a large cohort of children.
Since 2011 sulfur hexafluoride (SH, SonoVue®, Bracco, Italy) is the only ultrasound contrast available in the European Union and its use in children has not been approved. Within a 4-year-period, 531 children with suspected or proven vesicoureteral reflux (f/m = 478/53; mean age 4.9 years; 1 mo-25.2 years) following parental informed consent underwent VUS with administration of 2.6 ± 1.2 mL SH in a two-center study. A standardized telephone survey on adverse events was conducted three days later.
No acute adverse reactions were observed. The survey revealed subacute, mostly self-limited adverse events in 4.1% (22/531). The majority of observed adverse events (17/22) was not suspected to be caused by an allergic reaction: Five were related to catheter placement, three to reactivated urinary tract infections, five were associated with perineal disinfection before voiding urosonography or perineal dermatitis and four with a common cold. In five patients (0.9%) hints to a potential allergic cause were noted: Perineal urticaria was reported in three interviews and isolated, mild fever in two. These were minor self-limited adverse events with a subacute onset and no hospital admittance was necessary. Ninety-six point two percent of the parents would prefer future VUS examinations with use of SH.
No severe adverse events were observed and indications of self-limited minor allergic reactions related to intravesical administration of SH were reported in less than 1%.
Core tip: This was a two-center study on 531 children with suspected or proven vesicoureteral reflux undergoing off-label voiding urosonography using sulfur hexafluoride (SH). We investigated the SH risk profile with intravesical administration. No acute allergic adverse event was observed with the off-label-use of SH for radiation free assessment of vesicoureteral reflux. Only a few subacute, minor-to-moderate adverse events were reported (4.1%). Hints of self-limited minor allergic reaction related to intravesical administration of sulfur hexafluoride were reported in less than 1%. This underlines the demand for an approval of SH in pediatric applications.