Evaluating Phenylephrine for Low Blood Pressure in Teens Under Anesthesia

Phase 4 Open Label Study to Determine Pharmacokinetics of Phenylephrine and Pharmacodynamic Effects on BP Via IV Admin of Phenylephrine Hydrochloride Inj in Ped Subjects (≥12 to 16 Years of Age) Undergoing Gen and Neuraxial Anesthesia

This study is testing if a medication called Phenylephrine can help teens aged 12 to 16 with low blood pressure while they are under anesthesia.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 12 Years to 16 Years
• Sex: All
• Sponsor: West-Ward Pharmaceutical (industry)
• Locations: 10 sites (Wilmington, Delaware and 9 other locations)
• Trial ID: NCT02323399 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effects of Phenylephrine Hydrochloride Injection on blood pressure in pediatric patients aged 12 to 16 years who experience hypotension during general or neuraxial anesthesia. It is a Phase 4, multi-center, randomized open-label trial involving 100 subjects, with a focus on determining the pharmacokinetics and pharmacodynamics of the drug. Participants will receive either an intravenous bolus or a continuous infusion of Phenylephrine at varying doses, and the study will monitor changes in blood pressure, heart rate, and safety outcomes. The goal is to better understand how this medication can effectively manage low blood pressure in this specific population.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 16 years scheduled for procedures requiring general or neuraxial anesthesia who may experience low blood pressure.

Not a fit: Patients with contraindications to vasoconstrictor therapy or serious medical conditions that could interfere with the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective treatment option for managing hypotension in pediatric patients undergoing anesthesia.

How similar studies have performed: Other studies have explored the use of Phenylephrine in similar contexts, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject's age is between ≥12 and 16 years, inclusive
2. Subject is scheduled for a procedure that requires general or neuraxial anesthesia
3. Subjects must have normal or clinically acceptable physical exam
4. Subjects with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmHg (sitting, after 5 minutes of rest)
5. Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1
6. Subject's parent or legal guardian gives informed consent and subject gives assent.

Exclusion Criteria:

1. Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
2. Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
3. Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
4. Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration
5. Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody
6. Subjects taking antihypertensive medication
7. Subject is moribund (death is likely to occur in less than 48 hours)
8. Females who are pregnant, nursing or unwilling to use/practice adequate contraception.

Where this trial is running

Wilmington, Delaware and 9 other locations

• Alfred I. DuPont Hospital for Children — Wilmington, Delaware, United States (WITHDRAWN)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (TERMINATED)
• Jackson Memorial Hospital — Miami, Florida, United States (RECRUITING)
• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States (TERMINATED)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (TERMINATED)
• Stony Brook Medicine — Stony Brook, New York, United States (TERMINATED)
• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
• Children's Medical Center of Dallas — Dallas, Texas, United States (RECRUITING)
• Seattle Children's Hospital — Seattle, Washington, United States (WITHDRAWN)
• Ruby Memorial Hospital — Morgantown, West Virginia, United States (TERMINATED)

Study contacts

• Study coordinator: J. Barton Kalis

Conditions: Hypotension