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Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

NCT ID: NCT00894465

Last Updated: 2016-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vesicoureteral Reflux

Keywords

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Midazolam VCUG Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Versed

Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Children are randomized to receive a placebo prior to undergoing VCUG

Interventions

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midazolam

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

Intervention Type DRUG

placebo

Children are randomized to receive a placebo prior to undergoing VCUG

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Society of Pediatric Urology

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul F Austin, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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HRPO # 06-0665

Identifier Type: -

Identifier Source: org_study_id