Study of Phenylephrine for Low Blood Pressure in Teens

This study is looking at how different doses of phenylephrine hydrochloride injection affect blood pressure in teenagers (ages 12-16) who experience low blood pressure during surgery. Researchers want to understand how much phenylephrine is needed to treat low blood pressure, how quickly it works, and how long its effects last. They will also check the safety of phenylephrine in this age group and how the body processes the medication. You may be eligible if you are between 12 and 16 years old, are scheduled for surgery requiring general or neuraxial anesthesia, and have generally good health. The study aims to enroll 100 participants, but up to 300 may be enrolled to ensure enough participants experience low blood pressure during surgery and receive the study drug. The study's current status is unclear.

Study design
This is a Phase 4, multi-center, randomized, open-label study involving 100 subjects. Participants will receive one of six initial treatments of phenylephrine hydrochloride injection, either as an intravenous bolus (quick injection) or a continuous intravenous infusion (drip).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Plasma phenylephrine concentrations will be measured from screening up to Day 3.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02323399

Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV

UNKNOWN
PHASE4Ages 12–16InterventionalTreatment
West-Ward Pharmaceutical
~100 participants
Updated 2024-07-23 on ClinicalTrials.gov
What's tested:Phenylephrine

At a glance

Recruiting sites
3 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma Phenylephrine (PE) concentrations will be measured using a validated liquid chromatography/mass spectrometry (LCMS/MS) assay.
Measured over Screening up to Day 3
Hypotension
10 sites across 10 states
Delaware1
District of Columbia1
Florida1
Georgia1
Mississippi1
New York1
Ohio1
Texas1
  • Cesar Ormeno, MD · STUDY_DIRECTOR · PRA Health Sciences

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  • Plasma Phenylephrine (PE) concentrations will be measured using a validated liquid chromatography/mass spectrometry (LCMS/MS) assay.Screening up to Day 3