Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)
- 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
- 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.
- 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
Group Intervention Description Amphetamine and/or methylphenidate Amphetamine and/or methylphenidate Patients who took their amphetamine and/or methylphenidate the morning of surgery. Hold stimulant medication Hold stimulant medication Patients who did not take their stimulant medication the morning of surgery.
- Primary Outcome Measures
Name Time Method Heart Rate Day 1 Heart rate prior to anesthetic induction
- Secondary Outcome Measures
Name Time Method Mean Blood Pressure Day 1 Mean blood pressure prior to anesthetic induction
Diastolic Blood Pressure Day 1 Diastolic blood pressure prior to anesthetic induction
Systolic Blood Pressure Day 1 Systolic blood pressure prior to anesthetic induction
mYPAS Measurement in Patients Receiving Midazolam 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 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.
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States