A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram

Washington University School of Medicine1 site in 1 country44 target enrollmentAugust 2006

ConditionsVesicoureteral Reflux

Interventionsmidazolam placebo

Overview

Phase: Not Applicable
Intervention: midazolam
Conditions: Vesicoureteral Reflux
Sponsor: Washington University School of Medicine
Enrollment: 44
Locations: 1
Primary Endpoint: Anxiety Score From the Modified Yale Preoperative Anxiety Scale
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

August 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Versed

Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.

Intervention: midazolam

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.

Intervention: placebo

Outcomes

Primary Outcomes

Anxiety Score From the Modified Yale Preoperative Anxiety Scale

Time Frame: Waiting room, before catheterization, and after catheterization

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.