Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)
The 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram|
- To determine the efficacy of oral midazolam in reducing anxiety in children undergoing VCUG test for VUR [ Time Frame: 1day, 7 days, 14 days and 6 months ] [ Designated as safety issue: No ]
- To determine if there is a difference in parents' perception of their child's anxiety during VCUG after pretreatment. [ Time Frame: 1 day, 7 days, 14 days and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.
Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG
Placebo Comparator: Placebo
Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.
Children are randomized to receive a placebo prior to undergoing VCUG
|United States, Missouri|
|ST Louis, Missouri, United States, 63110|
|Principal Investigator:||Paul F Austin, MD||Washington University School of Medicine|