Off-label-use of sulfur-hexafluoride in voiding urosonography for diagnosis of vesicoureteral reflux in children:A survey on adverse events

摘要

AIM To evaluate the risk profile of sulfur hexafluoride in voiding urosonography(VUS) based on a large cohort of children.METHODS Since 2011 sulfur hexafluoride(SH,SonoV ue?,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 standardizedtelephone survey on adverse events was conducted three days later.RESULTS 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.CONCLUSION 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%.