The efficacy of oral midazolam for decreasing anxiety in children undergoing voiding cystourethrogram: a randomized, double-blind, placebo controlled study.

PURPOSE: Voiding cystourethrogram is an invasive test that evokes anxiety. Our primary aim was to determine whether midazolam is beneficial in decreasing anxiety in children who undergo voiding cystourethrogram. Secondary aims were an examination of parent anxiety, health care professional perceptions and post-procedure behavioral outcomes in children after voiding cystourethrogram. MATERIALS AND METHODS: A total of 44 children were randomized to placebo or oral midazolam before voiding cystourethrogram in double-blind fashion. The Modified Yale Preoperative Anxiety Scale was used to evaluate child behavior before and during voiding cystourethrogram, and the Post Hospitalization Behavior Questionnaire was used to investigate any short-term and intermediate-term behavioral outcomes. The State-Trait Anxiety Inventory was used to evaluate parent personal anxiety during voiding cystourethrogram. A separate questionnaire was administered to radiology staff. Statistical analysis included the 2-sample t and Fisher exact tests. RESULTS: There was no difference in Modified Yale Preoperative Anxiety Scale scores in children randomized to midazolam or placebo. There was also no significant difference in parent anxiety. Radiology care providers identified no reliable benefit when blinded to sedation vs placebo. We did not note any post-procedural behavior issues after voiding cystourethrogram at up to 6 months of followup. CONCLUSIONS: Midazolam may not significantly help with child or parent anxiety during voiding cystourethrogram. No reliable benefit was noted according to radiology health care provider perception and there was no significant post-procedural behavior benefit. Midazolam may not provide a significant benefit in decreasing anxiety during voiding cystourethrogram.

Combination therapy with desmopressin and an anticholinergic medication for nonresponders to desmopressin for monosymptomatic nocturnal enuresis: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: Desmopressin is an approved medical therapy for the treatment of monosymptomatic primary nocturnal enuresis. In cases of limited response to desmopressin, we have added anticholinergic therapy to desmopressin (combination therapy). To evaluate this treatment strategy, we examined the efficacy of combination therapy for primary nocturnal enuresis in desmopressin-nonresponders. METHODS: Only patients with primary nocturnal enuresis refractory to the maximal dosage of desmopressin were enrolled. Children with lower urinary tract symptoms or bowel dysfunction were excluded, on the basis of a 3-day, 24-hour, frequency-volume chart and elimination record. Children continued to take desmopressin and were assigned randomly, in a double-blind manner, to receive either extended-release anticholinergic medication or placebo. Patients were reassessed after 1 month of therapy, with a 1-week nocturnal record. RESULTS: Forty-one desmopressin-nonresponders were enrolled, and 7 patients were excluded because of noncompliance. The treatment groups were equally matched with respect to age, gender, functional bladder capacity, and number of wet nights per week. After 1 month of treatment, there was a significant reduction in the mean number of wet nights in the combination therapy group, compared with the placebo group. With a generalized estimating equation approach, there was a significant 66% decrease in the risk of a wet episode, compared with the placebo group. CONCLUSIONS: This study represents the first prospective, placebo-controlled trial examining the effect of desmopressin in combination with long-acting, anticholinergic, bladder-relaxing therapy for monosymptomatic primary nocturnal enuresis.