Randomized clinical trial of sedation with oral midazolam for voiding cystourethrography in children

Background: Voiding Cystourethrography (VCUG) is a distressing procedure for children. Conscious sedation with any drug that its dose would not influences the procedure is preferred. The aim of this study was to assess the effectiveness of conscious sedation using oral midazolam in children undergoing VCUG. Methods: From November 2008 to October 2009 period, 93 Patients (68 girls and 25 boys), age ranging from 24 months to 11 years old (mean, 5.8 years) were double blindly randomized to receive a placebo (water) or oral midazolam before the examination. The primary outcome measures were patients' cooperation, facility of the procedure, 48 hours post procedure memory of children, bladder urine residue and detection of Vesocoureteral reflex. The data were analysed by SPSS and categorical variables compared using t-test and continuous variables compared using Chi. Square and Fisher’s exact tests. Results: 93 children were randomizly divided in two groups. In midazolam group, 44(93.6%) patients had good cooperation but in the control group 26(56.5%) had bad cooperation and 19 patients (41.3%) very bad cooperation (P=0.000). In midazolam group, 36 children (76.6%) had easy separation from their parents but in control group 20 children (43.5%) had moderate resistant and 21(45.7%) severe resistant. (P=0.000). Eighteen (38 %) patients of the study group and twenty patients (43 %) of control group had VUR respectively (P=0.65). Conclusion: According to this study, midazolam is a useful sedation in children undergoing VCUG.