Pharmacokinetic Study of Synera™ in Neonates and Infants

Paused · Phase 4

Conditions studied: Pain

In brief

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

Key facts

Study ID

NCT00747669

Run by

ZARS Pharma Inc.

People needed

11

Starts

2008-09-01

Expected to finish

2013-04-01

Last updated by the study team

2012-03-23

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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