Trial Outcomes & Findings for Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG) (NCT NCT00894465)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

Waiting room, before catheterization, and after catheterization

Results posted on

2016-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	22	22
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Versed n=22 Participants 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 n=22 Participants 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 n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	3.59 years STANDARD_DEVIATION 0.9 • n=5 Participants	3.45 years STANDARD_DEVIATION 1.4 • n=7 Participants	3.52 years STANDARD_DEVIATION 1.15 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Versed n=22 Participants 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 n=22 Participants 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
Anxiety Score From the Modified Yale Preoperative Anxiety Scale Waiting Room	30.80 units on a scale Standard Deviation 13.97	25.72 units on a scale Standard Deviation 3.47
Anxiety Score From the Modified Yale Preoperative Anxiety Scale Before catheterization	44.51 units on a scale Standard Deviation 20.68	57.55 units on a scale Standard Deviation 29.34
Anxiety Score From the Modified Yale Preoperative Anxiety Scale After catheterization	79.01 units on a scale Standard Deviation 19.26	81.39 units on a scale Standard Deviation 29.86

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Versed n=22 Participants 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 n=22 Participants 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
Anxiety Score From the State-Trait Anxiety Inventory Mothers	10.07 units on a scale Standard Deviation 15.26	11.72 units on a scale Standard Deviation 13.75
Anxiety Score From the State-Trait Anxiety Inventory Fathers	13.54 units on a scale Standard Deviation 12.50	5.00 units on a scale Standard Deviation 7.35

Adverse Events

Versed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Austin

Washington University School of Medicine

Phone: (314) 454-6034

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place