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

Information source: Nationwide Children's Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Amphetamine and/or methylphenidate (Drug); Hold stimulant medication (Other)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Nationwide Children's Hospital

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Blood pressure

Secondary outcome:

Heart rate

Anxiety

Eligibility

Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.

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.

Locations and Contacts

Nationwide Children's Hospital, Columbus, Ohio 43205, United States
Additional Information

Starting date: November 2012
Last updated: February 4, 2015

Page last updated: August 20, 2015

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