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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

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Results First Submitted Date  ICMJE July 14, 2017
Results First Posted Date  ICMJE September 26, 2017
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE November 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
Heart Rate [ Time Frame: Day 1 ]
Heart rate prior to anesthetic induction
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
Blood pressure [ Time Frame: Day 1 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
  • Systolic Blood Pressure [ Time Frame: Day 1 ]
    Systolic blood pressure prior to anesthetic induction
  • Diastolic Blood Pressure [ Time Frame: Day 1 ]
    Diastolic blood pressure prior to anesthetic induction
  • Mean Blood Pressure [ Time Frame: Day 1 ]
    Mean blood pressure prior to anesthetic induction
  • mYPAS Measurement in Patients Receiving Midazolam [ Time Frame: Day 1 ]
    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.
  • mYPAS Measurement in Patients Not Receiving Midazolam [ Time Frame: Day 1 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
  • Heart rate [ Time Frame: Day 1 ]
  • Anxiety [ Time Frame: Day 1 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: Amphetamine and/or methylphenidate
    Patients who took their stimulant medication the day of surgery.
  • Other: Hold stimulant medication
    Patients who held their stimulant medication the day of surgery.
Study Arms  ICMJE
  • Active Comparator: Amphetamine and/or methylphenidate
    Patients who took their amphetamine and/or methylphenidate the morning of surgery.
    Intervention: Drug: Amphetamine and/or methylphenidate
  • Experimental: Hold stimulant medication
    Patients who did not take their stimulant medication the morning of surgery.
    Intervention: Other: Hold stimulant medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
50
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2012)
60
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients will be enrolled if they have been diagnosed with ADHD and have been taking amphetamines and/or methylphenidate for at least the last six months and are undergoing an outpatient surgical or diagnostic procedure.

Exclusion Criteria:

  • Patients will be excluded if they are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs, if they have an allergy to midazolam, or a have cardiac disease.
  • Procedures that entail the likelihood of blood transfusion will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740206
Other Study ID Numbers  ICMJE IRB12-00721
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Cartabuke, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nationwide Children's Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP