Phenylephrine for Low Blood Pressure

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: West-Ward Pharmaceutical

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the dose effect of Phenylephrine Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial anesthesia. The secondary objectives are to describe changes in blood pressure and heart rate, time to onset and to maximal response, and the duration of response; to assess the safety of the product in this population; and to characterize the pharmacokinetics of phenylephrine hydrochloride.

Research Team

Cesar Ormeno, MD

Principal Investigator

PRA Health Sciences

Eligibility Criteria

This trial is for kids aged 12-16 who need anesthesia for a procedure and have low blood pressure. They should be generally healthy, not pregnant, and not on blood pressure meds. Kids with serious health issues or recent infections can't join.

Inclusion Criteria

I have taken a pregnancy test that was negative.

I am scheduled for surgery that needs general or spinal anesthesia.

Subjects must have normal or clinically acceptable physical exam

Exclusion Criteria

I am not pregnant, nursing, and I use effective birth control.

I cannot take certain medications to control my blood pressure.

I haven't had a serious infection in the last 4 weeks.

Treatment Details

Interventions

• Phenylephrine (Vasoconstrictor)

Trial Overview The study tests how Phenylephrine Hydrochloride Injection affects blood pressure in young patients under anesthesia. It looks at dosage effects, changes in heart rate and blood pressure, response times, safety, and how the body processes the drug.

Participant Groups

Group I: Phenylephrine Experimental Treatment 1 Intervention

Phenylephrine Hydrochloride Injection, USP (United States Pharmacopeia) 10 mg/mL label claim

Phenylephrine is already approved in Canada for the following indications:

Approved in Canada as Sudafed PE for:

• Nasal congestion
• Hypotension

Who Is Running the Clinical Trial?

West-Ward Pharmaceutical

Lead Sponsor

Trials

4

Recruited

2,000+