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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

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Amphetamine and/or methylphenidate Other: Hold stimulant medication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Active Comparator: Amphetamine and/or methylphenidate
Patients who took their amphetamine and/or methylphenidate the morning of surgery.
Drug: Amphetamine and/or methylphenidate
Patients who took their stimulant medication the day of surgery.

Experimental: Hold stimulant medication
Patients who did not take their stimulant medication the morning of surgery.
Other: Hold stimulant medication
Patients who held their stimulant medication the day of surgery.




Primary Outcome Measures :
  1. Heart Rate [ Time Frame: Day 1 ]
    Heart rate prior to anesthetic induction


Secondary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: Day 1 ]
    Systolic blood pressure prior to anesthetic induction

  2. Diastolic Blood Pressure [ Time Frame: Day 1 ]
    Diastolic blood pressure prior to anesthetic induction

  3. Mean Blood Pressure [ Time Frame: Day 1 ]
    Mean blood pressure prior to anesthetic induction

  4. 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.


  5. 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.




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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740206


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
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Responsible Party: Richard Cartabuke, Co-Director of Outpatient Anesthesia Services, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01740206    
Other Study ID Numbers: IRB12-00721
First Posted: December 4, 2012    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Methylphenidate
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors