Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)
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|ClinicalTrials.gov Identifier: NCT00894465|
Recruitment Status : Terminated (Most pts requested to be treated with versed. It was difficult to randomize pts.)
First Posted : May 7, 2009
Results First Posted : December 9, 2016
Last Update Posted : December 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vesicoureteral Reflux||Drug: midazolam Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||August 2009|
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
- 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.
- Anxiety Score From the State-Trait Anxiety Inventory [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894465
|United States, Missouri|
|ST Louis, Missouri, United States, 63110|
|Principal Investigator:||Paul F Austin, MD||Washington University School of Medicine|