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:
Collaborator:
Society of Pediatric Urology
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00894465
First received: May 4, 2009
Last updated: March 9, 2011
Last verified: March 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • To determine the efficacy of oral midazolam in reducing anxiety in children undergoing VCUG test for VUR [ Time Frame: 1day, 7 days, 14 days and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if there is a difference in parents' perception of their child's anxiety during VCUG after pretreatment. [ Time Frame: 1 day, 7 days, 14 days and 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Early Recognition Center
  More Information

No publications provided

Responsible Party: Paul Austin, MD, Washington University
ClinicalTrials.gov Identifier: NCT00894465     History of Changes
Other Study ID Numbers: HRPO # 06-0665
Study First Received: May 4, 2009
Last Updated: March 9, 2011
Health Authority: United States: Institutional Review Board

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014