Pharmacokinetic Study of Synera™ in Neonates and Infants
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ClinicalTrials.gov Identifier: NCT00747669
Recruitment Status :
(Difficulty with enrollment)
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Layout table for eligibility information
Ages Eligible for Study:
up to 4 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.