BACKGROUND: Recent reports about cisapride have raised some concerns about the safety and efficacy of this medication in children. The aim of this study was to identify electrocardiographic changes and a predisposition to develop arrhythmias in children. METHODS: Patients were divided in 2 groups: 1) 63 children (mean age: 29 months) who received cisapride (0.2 mg/kg/dose 3 times/day), and 2) 57 children (mean age: 27 months) who did not receive cisapride (they served as controls). Both groups did not have any associated disease. Electrocardiogram (EKG) was performed to children when they were included in the study. The QT interval was corrected using Bazett's formula. Twenty-four-hour Holter recording was performed in children with prolonged QT interval (PQTI). When PQTI was identified in group 1, cisapride was discontinued and a new EKG was performed. RESULTS: Five children from group 1 and 6 from group 2 had PQTI. In 3 children with PQTI, the QTc interval returned to normal values when cisapride was discontinued. In children under 4 months of age, a statistical difference was found, with QTc interval being longer in group 2 (without cisapride) than in group 1. Holter recordings were normal in all children with PQTI. CONCLUSION: PQTI can be found in normal children with or without cisapride. In our study PQTI was not associated with any life-threatening event.
BACKGROUND: Recent reports about cisapride have raised some concerns about the safety and efficacy of this medication in children. The aim of this study was to identify electrocardiographic changes and a predisposition to develop arrhythmias in children. METHODS:Patients were divided in 2 groups: 1) 63 children (mean age: 29 months) who received cisapride (0.2 mg/kg/dose 3 times/day), and 2) 57 children (mean age: 27 months) who did not receive cisapride (they served as controls). Both groups did not have any associated disease. Electrocardiogram (EKG) was performed to children when they were included in the study. The QT interval was corrected using Bazett's formula. Twenty-four-hour Holter recording was performed in children with prolonged QT interval (PQTI). When PQTI was identified in group 1, cisapride was discontinued and a new EKG was performed. RESULTS: Five children from group 1 and 6 from group 2 had PQTI. In 3 children with PQTI, the QTc interval returned to normal values when cisapride was discontinued. In children under 4 months of age, a statistical difference was found, with QTc interval being longer in group 2 (without cisapride) than in group 1. Holter recordings were normal in all children with PQTI. CONCLUSION: PQTI can be found in normal children with or without cisapride. In our study PQTI was not associated with any life-threatening event.