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

Not Applicable
Completed
Conditions
Attention Deficit Hyperactivity Disorder
Interventions
Other: Hold stimulant medication
Registration Number
NCT01740206
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Amphetamine and/or methylphenidateAmphetamine and/or methylphenidatePatients who took their amphetamine and/or methylphenidate the morning of surgery.
Hold stimulant medicationHold stimulant medicationPatients who did not take their stimulant medication the morning of surgery.
Primary Outcome Measures
NameTimeMethod
Heart RateDay 1

Heart rate prior to anesthetic induction

Secondary Outcome Measures
NameTimeMethod
Mean Blood PressureDay 1

Mean blood pressure prior to anesthetic induction

Diastolic Blood PressureDay 1

Diastolic blood pressure prior to anesthetic induction

Systolic Blood PressureDay 1

Systolic blood pressure prior to anesthetic induction

mYPAS Measurement in Patients Receiving MidazolamDay 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 MidazolamDay 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.

Trial Locations

Locations (1)

Nationwide Children's Hospital

🇺🇸

Columbus, Ohio, United States

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