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

NCT ID: NCT01740206

Last Updated: 2017-09-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amphetamine and/or methylphenidate

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

Group Type ACTIVE_COMPARATOR

Amphetamine and/or methylphenidate

Intervention Type DRUG

Patients who took their stimulant medication the day of surgery.

Hold stimulant medication

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

Group Type EXPERIMENTAL

Hold stimulant medication

Intervention Type OTHER

Patients who held their stimulant medication the day of surgery.

Interventions

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Amphetamine and/or methylphenidate

Patients who took their stimulant medication the day of surgery.

Intervention Type DRUG

Hold stimulant medication

Patients who held their stimulant medication the day of surgery.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Richard Cartabuke

Co-Director of Outpatient Anesthesia Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB12-00721

Identifier Type: -

Identifier Source: org_study_id