Trial Outcomes & Findings for Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD) (NCT NCT01740206)

Results Overview

Heart rate prior to anesthetic induction

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Day 1

Results posted on

2017-09-26

Participant Flow

Two subjects with unknown ADHD medication status were excluded from the analysis.

Participant milestones

Participant milestones
Measure	Patients Taking ADHD Medication Patients who took their amphetamine and/or methylphenidate the morning of surgery.	Patients Not Taking ADHD Medication Patients who held their stimulant medication the day of surgery.
Overall Study STARTED	14	34
Overall Study COMPLETED	14	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Taking ADHD Medication n=14 Participants Patients who took their amphetamine and/or methylphenidate the morning of surgery.	Patients Not Taking ADHD Medication n=34 Participants Patients who held their stimulant medication the day of surgery.	Total n=48 Participants Total of all reporting groups
Age, Continuous	9.25 years STANDARD_DEVIATION 2.56 • n=5 Participants	9.35 years STANDARD_DEVIATION 2.79 • n=7 Participants	9.32 years STANDARD_DEVIATION 2.70 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	23 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Heart rate prior to anesthetic induction

Outcome measures

Outcome measures
Measure	Patients Taking ADHD Medication n=14 Participants Patients who took their amphetamine and/or methylphenidate the morning of surgery.	Patients Not Taking ADHD Medication n=34 Participants Patients who held their stimulant medication the day of surgery.
Heart Rate	96.7 BPM Standard Deviation 13.9	88 BPM Standard Deviation 14

SECONDARY outcome

Timeframe: Day 1

Systolic blood pressure prior to anesthetic induction

Outcome measures

Outcome measures
Measure	Patients Taking ADHD Medication n=14 Participants Patients who took their amphetamine and/or methylphenidate the morning of surgery.	Patients Not Taking ADHD Medication n=34 Participants Patients who held their stimulant medication the day of surgery.
Systolic Blood Pressure	113.6 mmHg Standard Deviation 13.5	109.2 mmHg Standard Deviation 12.4

SECONDARY outcome

Timeframe: Day 1

Diastolic blood pressure prior to anesthetic induction

Outcome measures

Outcome measures
Measure	Patients Taking ADHD Medication n=14 Participants Patients who took their amphetamine and/or methylphenidate the morning of surgery.	Patients Not Taking ADHD Medication n=34 Participants Patients who held their stimulant medication the day of surgery.
Diastolic Blood Pressure	71.1 mmHg Standard Deviation 11	67.9 mmHg Standard Deviation 9.3

SECONDARY outcome

Timeframe: Day 1

Mean blood pressure prior to anesthetic induction

Outcome measures

Outcome measures
Measure	Patients Taking ADHD Medication n=14 Participants Patients who took their amphetamine and/or methylphenidate the morning of surgery.	Patients Not Taking ADHD Medication n=34 Participants Patients who held their stimulant medication the day of surgery.
Mean Blood Pressure	85.3 mmHg Standard Deviation 10.5	81.7 mmHg Standard Deviation 8.6

SECONDARY outcome

Timeframe: Day 1

Population: Of the 48 subjects analyzed, 10 subjects received midazolam prior to their surgical procedure.

modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction. Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \[(A + V + E + S +U)/5\] x 100. Higher score = more anxiety.

Outcome measures

Outcome measures
Measure	Patients Taking ADHD Medication n=4 Participants Patients who took their amphetamine and/or methylphenidate the morning of surgery.	Patients Not Taking ADHD Medication n=6 Participants Patients who held their stimulant medication the day of surgery.
mYPAS Measurement in Patients Receiving Midazolam	30 scores on a scale Interval 26.0 to 33.0	26 scores on a scale Interval 23.0 to 42.0

SECONDARY outcome

Timeframe: Day 1

Population: Of the 48 subjects analyzed, 38 subjects did not receive midazolam prior to their surgical procedure.

modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction. Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \[(A + V + E + S +U)/5\] x 100. Higher score = more anxiety.

Outcome measures

Outcome measures
Measure	Patients Taking ADHD Medication n=10 Participants Patients who took their amphetamine and/or methylphenidate the morning of surgery.	Patients Not Taking ADHD Medication n=28 Participants Patients who held their stimulant medication the day of surgery.
mYPAS Measurement in Patients Not Receiving Midazolam	28 scores on a scale Interval 23.0 to 42.0	28 scores on a scale Interval 23.0 to 28.0

Adverse Events

Patients Taking ADHD Medication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients Not Taking ADHD Medication

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

Richard Cartabuke, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place