RESUMEN
OBJECTIVE: Voiding cystourethrography (VCU) is a distressing procedure for children. Conscious sedation using oral midazolam may reduce this distress, but its use may also alter the ability of the VCU to show vesicoureteric reflux (VUR). The objectives of our study were to assess the effectiveness of conscious sedation using oral midazolam when administered routinely in children undergoing VCU and to ensure that conscious sedation using oral midazolam does not alter the ability of VCU to show VUR. SUBJECTS AND METHODS: Our study was a randomized double-blind controlled trial performed at a university teaching hospital; our study group consisted of children over the age of 1 year who been referred for their first VCU examination from July 2001 to July 2003. Participants were randomized to receive a placebo or midazolam syrup (0.5 mg/kg) before the examination. The primary outcome measures were the Groningen Distress Rating Scale (GDRS) and grading of VUR, as defined by the international grading system established by the International Reflux Study Group. RESULTS: There were no serious adverse events. One hundred thirty-nine children were randomized in the study, and 117 underwent complete assessment. Eight who underwent VCU after the study day were included in a "complete case" intention-to-treat analysis. In the placebo group, 34 children (61%) experienced serious distress or severe distress (GDRS score, 3 or 4). In the midazolam group, 16 children (26%) experienced the same degree of distress. There was a significant difference between the GDRS scores (nonlinear mixed-model analysis, p < 0.001) of the two study groups. The number needed to treat to reduce serious or severe distress in one child was 2.9 (95% CI, 1.9-5.5). VUR was identified in 16% of all children. There was no difference in VUR grading between the groups (nonlinear mixed-model analysis, p = 0.31). CONCLUSION: Routine use of oral midazolam (0.5 mg/kg) for conscious sedation of children undergoing VCU reduces distress and does not alter the ability of VCU to show VUR well enough to allow diagnosis.