Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

Not Applicable

Terminated

• Conditions: Vesicoureteral Reflux
• Interventions: Drug: placebo; Drug: midazolam

• Registration Number: NCT00894465
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-06
• Study First Posted: 2009-05-07
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Results First Submitted: 2016-01-24
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-17
• Last Update Submitted: 2016-10-17
• Results First Posted: 2016-12-09
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Versed	midazolam	Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.

Primary Outcome Measures

Name	Time	Method
Anxiety Score From the Modified Yale Preoperative Anxiety Scale	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety Score From the State-Trait Anxiety Inventory	At the time of the procedure	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.

Trial Locations

Locations (1)

Washington University; 🇺🇸 ST Louis, Missouri, United States