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

• 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: Nationwide Children's Hospital
• Information provided by (Responsible Party): Richard Cartabuke, Nationwide Children's Hospital

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

More Information

• 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
• Results First Posted: September 26, 2017
• Last Update Posted: September 26, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

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