Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

Vesicoureteral Reflux Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00894465
• Other study ID #: HRPO # 06-0665
• Status: Terminated
• Phase: N/A
• First received: May 4, 2009
• Last updated: March 9, 2011
• Start date: August 2006
• Est. completion date: August 2009

Study information

• Verified date: March 2011
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Vesico-Ureteral Reflux
• Vesicoureteral Reflux

Intervention

Drug:
• midazolam
Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG
• placebo
Children are randomized to receive a placebo prior to undergoing VCUG

Locations

Country	Name	City	State
United States	Washington University	ST Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Society of Pediatric Urology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of oral midazolam in reducing anxiety in children undergoing VCUG test for VUR		1day, 7 days, 14 days and 6 months	No
Secondary	To determine if there is a difference in parents' perception of their child's anxiety during VCUG after pretreatment.		1 day, 7 days, 14 days and 6 months	No