Vesicoureteral Reflux
Conditions
Keywords
Midazolam, VCUG, Anxiety
Brief 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.
Interventions
DRUGmidazolam
Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG
DRUGplacebo
Children are randomized to receive a placebo prior to undergoing VCUG
Sponsors
Society of Pediatric Urology
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Score From the Modified Yale Preoperative Anxiety Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Score From the State-Trait Anxiety Inventory | At the time of the procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Placebo | Versed | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 22 Participants | 44 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.45 years STANDARD_DEVIATION 1.4 | 3.59 years STANDARD_DEVIATION 0.9 | 3.52 years STANDARD_DEVIATION 1.15 |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 42 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
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.
Time frame: Waiting room, before catheterization, and after catheterization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Versed | Anxiety Score From the Modified Yale Preoperative Anxiety Scale | Waiting Room | 30.80 units on a scale | Standard Deviation 13.97 |
| Versed | Anxiety Score From the Modified Yale Preoperative Anxiety Scale | Before catheterization | 44.51 units on a scale | Standard Deviation 20.68 |
| Versed | Anxiety Score From the Modified Yale Preoperative Anxiety Scale | After catheterization | 79.01 units on a scale | Standard Deviation 19.26 |
| Placebo | Anxiety Score From the Modified Yale Preoperative Anxiety Scale | Waiting Room | 25.72 units on a scale | Standard Deviation 3.47 |
| Placebo | Anxiety Score From the Modified Yale Preoperative Anxiety Scale | Before catheterization | 57.55 units on a scale | Standard Deviation 29.34 |
| Placebo | Anxiety Score From the Modified Yale Preoperative Anxiety Scale | After catheterization | 81.39 units on a scale | Standard Deviation 29.86 |
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.
Time frame: At the time of the procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Versed | Anxiety Score From the State-Trait Anxiety Inventory | Mothers | 10.07 units on a scale | Standard Deviation 15.26 |
| Versed | Anxiety Score From the State-Trait Anxiety Inventory | Fathers | 13.54 units on a scale | Standard Deviation 12.5 |
| Placebo | Anxiety Score From the State-Trait Anxiety Inventory | Fathers | 5.00 units on a scale | Standard Deviation 7.35 |
| Placebo | Anxiety Score From the State-Trait Anxiety Inventory | Mothers | 11.72 units on a scale | Standard Deviation 13.75 |