Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

NCT00894465 | Terminated Results

• 1 other identifier: HRPO # 06-0665
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesicoureteral Reflux

Keywords

Midazolam; VCUG; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Anxiety Score From the State-Trait Anxiety Inventory

  At the time of the procedure

Study Arms (2)

Versed

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

midazolam DRUG

Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG

Versed

placebo DRUG

Children are randomized to receive a placebo prior to undergoing VCUG

Placebo

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 2-6 years
• Toilet trained
• English speaking
• Already scheduled for VCUG

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Society of Pediatric Urology: collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux; Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Paul Austin
• Organization: Washington University School of Medicine

austinp@wustl.edu

(314) 454-6034

Study Officials

• Paul F Austin, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 7, 2009
• Study Start: August 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 9, 2016
• Results First Posted: December 9, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)