Pharmacokinetic Study of Synera™ in Neonates and Infants

ZARS Pharma

Status and phase

Suspended

Phase 4

Conditions

Pain

Treatments

Drug: lidocaine 70mg and tetracaine 70mg topical patch

Study type

Interventional

Funder types

Industry

Identifiers

EN3274-401

Details and patient eligibility

About

This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.

Enrollment

11 estimated patients

Sex

All

Ages

Under 4 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.
Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.
Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.
The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.

Exclusion criteria

Subject has known allergies or sensitivities to any component of Synera.
Subject has clinically significant laboratory abnormalities.
Subject has known multiple allergies that could indicate hypersensitive skin.
Subject has known active atopic dermatitis at or near the patch application site.