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

NCT01740206 | Completed Results

• 1 other identifier: IRB12-00721
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Heart Rate

  Heart rate prior to anesthetic induction

  Day 1

Secondary Outcomes (5)

• Systolic Blood Pressure

  Day 1

• Diastolic Blood Pressure

  Day 1

• Mean Blood Pressure

  Day 1

• mYPAS Measurement in Patients Receiving Midazolam

  Day 1

• mYPAS Measurement in Patients Not Receiving Midazolam

  Day 1

Study Arms (2)

Amphetamine and/or methylphenidate

ACTIVE COMPARATOR

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

Drug: Amphetamine and/or methylphenidate

Hold stimulant medication

EXPERIMENTAL

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

Other: Hold stimulant medication

Interventions

Amphetamine and/or methylphenidate DRUG

Patients who took their stimulant medication the day of surgery.

Amphetamine and/or methylphenidate

Hold stimulant medication OTHER

Patients who held their stimulant medication the day of surgery.

Hold stimulant medication

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Richard Cartabuke, MD
• Organization: Nationwide Children's Hospital

Richard.Cartabuke@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of Outpatient Anesthesia Services

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 26, 2017
• Results First Posted: September 26, 2017

Record last verified: 2017-07

Locations

US (1)