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

Nationwide Children's Hospital

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Other: Hold stimulant medication; Drug: Amphetamine and/or methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT01740206

IRB12-00721

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Amphetamine and/or methylphenidate

Active Comparator group

Description:

Patients who took their amphetamine and/or methylphenidate the morning of surgery.

Treatment:

Drug: Amphetamine and/or methylphenidate

Hold stimulant medication

Experimental group

Description:

Patients who did not take their stimulant medication the morning of surgery.

Treatment:

Other: Hold stimulant medication