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Most pts requested to be treated with versed. It was difficult to randomize pts.
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| Name | Class |
|---|---|
| Society of Pediatric Urology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam | Drug | Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Waiting room, before catheterization, and after catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul F Austin, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who signed consent were included in analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Waiting room, before catheterization, and after catheterization |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Austin | Washington University School of Medicine | (314) 454-6034 | austinp@wustl.edu |
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| ID | Term |
|---|---|
| D014718 | Vesico-Ureteral Reflux |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| placebo | Drug | Children are randomized to receive a placebo prior to undergoing VCUG |
|
| At the time of the procedure |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | At the time of the procedure |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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 | 0 | 22 | 0 | 22 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |