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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740206
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Richard Cartabuke, Nationwide Children's Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: Amphetamine and/or methylphenidate
Other: Hold stimulant medication
Enrollment 50
Recruitment Details  
Pre-assignment Details Two subjects with unknown ADHD medication status were excluded from the analysis.
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Hide Arm/Group Description Patients who took their amphetamine and/or methylphenidate the morning of surgery. Patients who held their stimulant medication the day of surgery.
Period Title: Overall Study
Started 14 34
Completed 14 34
Not Completed 0 0
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication Total
Hide Arm/Group Description Patients who took their amphetamine and/or methylphenidate the morning of surgery. Patients who held their stimulant medication the day of surgery. Total of all reporting groups
Overall Number of Baseline Participants 14 34 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 34 participants 48 participants
9.25  (2.56) 9.35  (2.79) 9.32  (2.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 34 participants 48 participants
Female
3
  21.4%
11
  32.4%
14
  29.2%
Male
11
  78.6%
23
  67.6%
34
  70.8%
1.Primary Outcome
Title Heart Rate
Hide Description Heart rate prior to anesthetic induction
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Hide Arm/Group Description:
Patients who took their amphetamine and/or methylphenidate the morning of surgery.
Patients who held their stimulant medication the day of surgery.
Overall Number of Participants Analyzed 14 34
Mean (Standard Deviation)
Unit of Measure: BPM
96.7  (13.9) 88  (14)
2.Secondary Outcome
Title Systolic Blood Pressure
Hide Description Systolic blood pressure prior to anesthetic induction
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Hide Arm/Group Description:
Patients who took their amphetamine and/or methylphenidate the morning of surgery.
Patients who held their stimulant medication the day of surgery.
Overall Number of Participants Analyzed 14 34
Mean (Standard Deviation)
Unit of Measure: mmHg
113.6  (13.5) 109.2  (12.4)
3.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description Diastolic blood pressure prior to anesthetic induction
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Hide Arm/Group Description:
Patients who took their amphetamine and/or methylphenidate the morning of surgery.
Patients who held their stimulant medication the day of surgery.
Overall Number of Participants Analyzed 14 34
Mean (Standard Deviation)
Unit of Measure: mmHg
71.1  (11) 67.9  (9.3)
4.Secondary Outcome
Title Mean Blood Pressure
Hide Description Mean blood pressure prior to anesthetic induction
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Hide Arm/Group Description:
Patients who took their amphetamine and/or methylphenidate the morning of surgery.
Patients who held their stimulant medication the day of surgery.
Overall Number of Participants Analyzed 14 34
Mean (Standard Deviation)
Unit of Measure: mmHg
85.3  (10.5) 81.7  (8.6)
5.Secondary Outcome
Title mYPAS Measurement in Patients Receiving Midazolam
Hide Description

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.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 48 subjects analyzed, 10 subjects received midazolam prior to their surgical procedure.
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Hide Arm/Group Description:
Patients who took their amphetamine and/or methylphenidate the morning of surgery.
Patients who held their stimulant medication the day of surgery.
Overall Number of Participants Analyzed 4 6
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
30
(26 to 33)
26
(23 to 42)
6.Secondary Outcome
Title mYPAS Measurement in Patients Not Receiving Midazolam
Hide Description

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.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 48 subjects analyzed, 38 subjects did not receive midazolam prior to their surgical procedure.
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Hide Arm/Group Description:
Patients who took their amphetamine and/or methylphenidate the morning of surgery.
Patients who held their stimulant medication the day of surgery.
Overall Number of Participants Analyzed 10 28
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
28
(23 to 42)
28
(23 to 28)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Hide Arm/Group Description Patients who took their amphetamine and/or methylphenidate the morning of surgery. Patients who held their stimulant medication the day of surgery.
All-Cause Mortality
Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/34 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients Taking ADHD Medication Patients Not Taking ADHD Medication
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/34 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard Cartabuke, MD
Organization: Nationwide Children's Hospital
Phone: 614-722-4200
EMail: Richard.Cartabuke@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Richard Cartabuke, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01740206    
Other Study ID Numbers: IRB12-00721
First Submitted: November 30, 2012
First Posted: December 4, 2012
Results First Submitted: July 14, 2017
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017