Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

Washington University School of Medicine44 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Vesicoureteral Reflux

Interventions

midazolamDRUG

Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG

placeboDRUG

Children are randomized to receive a placebo prior to undergoing VCUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Washington University

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Anxiety Score From the Modified Yale Preoperative Anxiety Scale

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.

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

Secondary Outcomes

Anxiety Score From the State-Trait Anxiety Inventory

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.

Time frame: At the time of the procedure

Data from ClinicalTrials.gov

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