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Completed

NCT Number: NCT01740206

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

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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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amphetamine and/or methylphenidate

Drug

Patients who took their stimulant medication the day of surgery.

Hold stimulant medication

Other

Patients who held their stimulant medication the day of surgery.

Primary outcomes

  1. Heart Rate

    Time frame: Day 1

    Heart rate prior to anesthetic induction

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2012
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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