Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

The Washington University

Status: Terminated

Conditions: Vesicoureteral Reflux

Treatments: Drug: midazolam; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00894465

HRPO # 06-0665

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

44 participants in 2 patient groups, including a placebo group

Versed

Experimental group

Description:

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

Treatment:

Drug: midazolam

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo