Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

• ClinicalTrials.gov Identifier: NCT00894465
• Recruitment Status: Terminated
• First Posted: May 7, 2009
• Results First Posted: December 9, 2016
• Last Update Posted: December 9, 2016
• Sponsor: Washington University School of Medicine
• Collaborator: Society of Pediatric Urology
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Vesicoureteral Reflux	Drug: midazolam; Drug: placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• 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
• Study Start Date: August 2006
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

• 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

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
• Other Study ID Numbers: HRPO # 06-0665
• First Posted: May 7, 2009
• 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