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Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be randomized to one of two groups: stimulant medication administered on the day of surgery or stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology will be at the discretion of the attending anesthesiologist, but the endpoint will be a bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia. Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and the incidence of hypotension, bradycardia, or administration of medications will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphetamine and/or methylphenidate | Active Comparator | Patients who took their amphetamine and/or methylphenidate the morning of surgery. |
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| Hold stimulant medication | Experimental | Patients who did not take their stimulant medication the morning of surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphetamine and/or methylphenidate | Drug | Patients who took their stimulant medication the day of surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate prior to anesthetic induction | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic blood pressure prior to anesthetic induction | Day 1 |
| Diastolic Blood Pressure | Diastolic blood pressure prior to anesthetic induction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
Two subjects with unknown ADHD medication status were excluded from the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Taking ADHD Medication | Patients who took their amphetamine and/or methylphenidate the morning of surgery. |
| FG001 | Patients Not Taking ADHD Medication | Patients who held their stimulant medication the day of surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Hold stimulant medication | Other | Patients who held their stimulant medication the day of surgery. |
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| Day 1 |
| Mean Blood Pressure | Mean blood pressure prior to anesthetic induction | Day 1 |
| mYPAS Measurement in Patients Receiving Midazolam | 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. | Day 1 |
| mYPAS Measurement in Patients Not Receiving Midazolam | 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. | Day 1 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Taking ADHD Medication | Patients who took their amphetamine and/or methylphenidate the morning of surgery. |
| BG001 | Patients Not Taking ADHD Medication | Patients who held their stimulant medication the day of surgery. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Heart Rate | Heart rate prior to anesthetic induction | Posted | Mean | Standard Deviation | BPM | Day 1 |
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| Secondary | Systolic Blood Pressure | Systolic blood pressure prior to anesthetic induction | Posted | Mean | Standard Deviation | mmHg | Day 1 |
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| Secondary | Diastolic Blood Pressure | Diastolic blood pressure prior to anesthetic induction | Posted | Mean | Standard Deviation | mmHg | Day 1 |
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| Secondary | Mean Blood Pressure | Mean blood pressure prior to anesthetic induction | Posted | Mean | Standard Deviation | mmHg | Day 1 |
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| Secondary | mYPAS Measurement in Patients Receiving Midazolam | 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. | Of the 48 subjects analyzed, 10 subjects received midazolam prior to their surgical procedure. | Posted | Median | Inter-Quartile Range | scores on a scale | Day 1 |
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| Secondary | mYPAS Measurement in Patients Not Receiving Midazolam | 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. | Of the 48 subjects analyzed, 38 subjects did not receive midazolam prior to their surgical procedure. | Posted | Median | Inter-Quartile Range | scores on a scale | Day 1 |
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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 | Patients Taking ADHD Medication | Patients who took their amphetamine and/or methylphenidate the morning of surgery. | 0 | 14 | 0 | 14 | ||
| EG001 | Patients Not Taking ADHD Medication | Patients who held their stimulant medication the day of surgery. | 0 | 34 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Cartabuke, MD | Nationwide Children's Hospital | 614-722-4200 | Richard.Cartabuke@nationwidechildrens.org |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Male |
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