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Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

This study has been terminated.
(Most pts requested to be treated with versed. It was difficult to randomize pts.)
Sponsor:
Collaborator:
Society of Pediatric Urology
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00894465
First received: May 4, 2009
Last updated: October 17, 2016
Last verified: October 2016
Results First Received: January 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Condition: Vesicoureteral Reflux
Interventions: Drug: midazolam
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Versed

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

midazolam: 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.

placebo: Children are randomized to receive a placebo prior to undergoing VCUG


Participant Flow:   Overall Study
    Versed   Placebo
STARTED   22   22 
COMPLETED   22   22 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who signed consent were included in analysis population.

Reporting Groups
  Description
Versed

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

midazolam: 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.

placebo: Children are randomized to receive a placebo prior to undergoing VCUG

Total Total of all reporting groups

Baseline Measures
   Versed   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   22   44 
Age 
[Units: Participants]
     
<=18 years   22   22   44 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.59  (0.9)   3.45  (1.4)   3.52  (1.15) 
Gender 
[Units: Participants]
     
Female   22   20   42 
Male   0   2   2 
Region of Enrollment 
[Units: Participants]
     
United States   22   22   44 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Anxiety Score From the Modified Yale Preoperative Anxiety Scale   [ Time Frame: Waiting room, before catheterization, and after catheterization ]

2.  Secondary:   Anxiety Score From the State-Trait Anxiety Inventory   [ Time Frame: At the time of the procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Paul Austin
Organization: Washington University School of Medicine
phone: (314) 454-6034
e-mail: austinp@wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00894465     History of Changes
Other Study ID Numbers: HRPO # 06-0665
Study First Received: May 4, 2009
Results First Received: January 24, 2016
Last Updated: October 17, 2016
Health Authority: United States: Institutional Review Board