Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

Study Overview
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Brief Summary
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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.

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

Conditions
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Vesicoureteral Reflux

Intervention / Treatment
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* Drug: midazolam
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Versed<br>Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG. | Drug: midazolam<br>* Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG<br>|
| Placebo Comparator: Placebo<br>Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG. | Drug: placebo<br>* Children are randomized to receive a placebo prior to undergoing VCUG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Waiting room, before catheterization, and after catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the time of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, VCUG, Anxiety