Vesicoureteral RefluxNCT00894465
Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)
A study testing midazolam in people with Vesicoureteral Reflux, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Vesicoureteral Reflux
- What is being tested?
- midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 2-6 years
- Toilet trained
- English speaking
- Already scheduled for VCUG
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram
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
- Being tested
- midazolam, placebo
- Keywords
- Midazolam, VCUG, Anxiety
- Medical subject headings
- Vesico-Ureteral Reflux, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG
placeboDrug
Children are randomized to receive a placebo prior to undergoing VCUG
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Waiting room, before catheterization, and after catheterization
Secondary outcomes (1)
Anxiety Score From the State-Trait Anxiety Inventory
The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. This questionnaire was used to evaluate the anxiety level of the parents of the children who randomized to versed or placebo.
Measured: At the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startAug 2006
- Primary completionJun 2009
- Study completionAug 2009
Why it stopped: Most pts requested to be treated with versed. It was difficult to randomize pts.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Pediatric Urology
- Responsible party
- Sponsor
- Investigators
- Paul F Austin, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894465
- Sponsor's protocol ID
- HRPO # 06-0665
- Status last verified
- Oct 2016
- First submitted
- 4 May 2009
- Last updated
- 9 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram
- ClinicalTrials.gov ID
- NCT00894465
- Acronym / sponsor ID
- HRPO # 06-0665
- Conditions
- Vesicoureteral Reflux
- Keywords
- Midazolam, VCUG, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Most pts requested to be treated with versed. It was difficult to randomize pts.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Society of Pediatric Urology
- Study start
- Aug 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 9 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Versed | Experimental | Drug: midazolamBoth patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG. |
| Placebo | Placebo comparator | Drug: placeboBoth patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 2-6 years
- Toilet trained
- English speaking
- Already scheduled for VCUG
Key exclusion criteria (8 listed)
- Allergic to midazolam
- Active UTI
- Known urethral stricture
- Known urethral reconstruction
- Has history of abnormal sensation in pelvic area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolamChildren are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG | Drug | Versed |
| placeboChildren are randomized to receive a placebo prior to undergoing VCUG | Drug | Placebo |
Primary outcome
Anxiety Score From the Modified Yale Preoperative Anxiety Scale
Time frame: Waiting room, before catheterization, and after catheterization
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.
1 secondary outcome
Anxiety Score From the State-Trait Anxiety Inventory
Time frame: At the time of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F Austin, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midazolam in people with Vesicoureteral Reflux, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Score From the Modified Yale Preoperative Anxiety Scale (time frame: Waiting room, before catheterization, and after catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.