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Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

This study has been terminated.
(Most pts requested to be treated with versed. It was difficult to randomize pts.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894465
First Posted: May 7, 2009
Last Update Posted: December 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Society of Pediatric Urology
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition Intervention
Vesicoureteral Reflux Drug: midazolam Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: August 2006
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Versed
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
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.
Drug: placebo
Children are randomized to receive a placebo prior to undergoing VCUG

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Missouri
Washington University
ST Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Society of Pediatric Urology
Investigators
Principal Investigator: Paul F Austin, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00894465     History of Changes
Other Study ID Numbers: HRPO # 06-0665
First Submitted: May 4, 2009
First Posted: May 7, 2009
Results First Submitted: January 24, 2016
Results First Posted: December 9, 2016
Last Update Posted: December 9, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:
Midazolam
VCUG
Anxiety

Additional relevant MeSH terms:
Vesico-Ureteral Reflux
Urinary Bladder Diseases
Urologic Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action