Title
Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)
A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram
Phase
N/ALead Sponsor
Washington University in St. LouisStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Vesicoureteral RefluxIntervention/Treatment
midazolam ...Study Participants
44The purpose of this research is to validate the common administration of oral midazolam to children prior to voiding cystourethrogram (VCUG) to see if this will significantly decrease children's anxiety and make the experience less traumatic.
Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG
Children are randomized to receive a placebo prior to undergoing VCUG
Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.
Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.
Inclusion Criteria: Age 2-6 years Toilet trained English speaking Already scheduled for VCUG Exclusion Criteria: Allergic to midazolam Active UTI Known urethral stricture Known urethral reconstruction Has history of abnormal sensation in pelvic area Has history of sexual abuse Has severe developmental delay Has diagnosis of anxiety disorders
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The modified Yale preoperative scale consists of 5 categories (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Four of the five categories are scored between 1-4 points and one of the categories is scored from 1-6 points. The scores are divided by their number of possible points in their respective category and multiplied by 20 to get the final anxiety score which ranges from 20 to 100. Low numbers represent low anxiety and higher numbers represent high anxiety.
The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. This questionnaire was used to evaluate the anxiety level of the parents of the children who randomized to versed or placebo.
