Phase
Condition
Dizzy/fainting Spells
Vascular Diseases
Circulation Disorders
Treatment
Phenylephrine
Clinical Study ID
Ages 12-16 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject's age is between ≥12 and 16 years, inclusive
Subject is scheduled for a procedure that requires general or neuraxial anesthesia
Subjects must have normal or clinically acceptable physical exam
Subjects with controlled diabetes prior to entry must have a mean systolic/diastolicoffice blood pressure ≤128/78 mmHg (sitting, after 5 minutes of rest)
Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin)that is negative at Screening and Day 1
Subject's parent or legal guardian gives informed consent and subject gives assent.
Exclusion
Exclusion Criteria:
Subject has a contraindication to vasoconstrictor therapy for control of bloodpressure
Subject has participated in other clinical trials for investigational drugs and/ordevices within 30 days prior to enrollment
Subject has any serious medical condition which, in the opinion of the investigator,is likely to interfere with study procedures
Subjects who have a history of any clinically significant local or systemicinfectious disease within four weeks prior to initial treatment administration
Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody
Subjects taking antihypertensive medication
Subject is moribund (death is likely to occur in less than 48 hours)
Females who are pregnant, nursing or unwilling to use/practice adequatecontraception.
Study Design
Study Description
Connect with a study center
Alfred I. DuPont Hospital for Children
Wilmington, Delaware 19803
United StatesSite Not Available
Children's National Medical Center
Washington, District of Columbia 20010
United StatesTerminated
Children's National Medical Center
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
Jackson Memorial Hospital
Miami, Florida 33136-1005
United StatesActive - Recruiting
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia 30322-1062
United StatesTerminated
University of Mississippi Medical Center
Jackson, Mississippi 39126
United StatesTerminated
Stony Brook Medicine
Stony Brook, New York 11794
United StatesTerminated
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Children's Medical Center of Dallas
Dallas, Texas 75390
United StatesActive - Recruiting
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
Ruby Memorial Hospital
Morgantown, West Virginia 26506
United StatesTerminated
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