Most pts requested to be treated with versed. It was difficult to randomize pts.
A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram
Sponsor study identifier
interventional
44
1 country
1
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
August 2009
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
May 4, 2009
Actual (reported)May 7, 2009
Actual (reported)June 2009
Actual (reported)August 2009
Actual (reported)December 9, 2016
Actual (reported)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
Anxiety Score From the State-Trait Anxiety Inventory
At the time of the procedure
Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.
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 oral midazolam .5 mg/kg prior to undergoing VCUG
Children are randomized to receive a placebo prior to undergoing VCUG
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Washington University
St Louis, Missouri, 63110, United States
Paul F Austin, MD
Washington University School of Medicine
44 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2009
First Posted
May 7, 2009
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2009
Actual (reported)Study Completion
August 2009
Actual (reported)Last Updated
December 9, 2016
Results First Posted
December 9, 2016
Record last verified: 2016-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: