Pharmacokinetic Study of Synera™ in Neonates and Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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lidocaine 70mg and tetracaine 70mg topical patch

One Synera Patch applied for 30 minutes.

Intervention Type DRUG

Other Intervention Names

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Synera

Eligibility Criteria

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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.

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No