Evaluate the Depth and Duration of Anesthesia
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/14/2017 |
| Start Date: | December 2006 |
| End Date: | April 2007 |
A Randomized, Double-Blind, Two-Period, Crossover Study to Evaluate the Depth and Duration of Anesthesia of Synera™ Patches Compared to Placebo Patches Applied to Healthy Adult Volunteers
The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera
topical patch (using sensory depth and pain depth evaluations), and to determine the duration
(minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing
and thermal sensory testing evaluations), compared with a matching heated placebo patch.
topical patch (using sensory depth and pain depth evaluations), and to determine the duration
(minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing
and thermal sensory testing evaluations), compared with a matching heated placebo patch.
Inclusion Criteria:
- Had no known significant diseases
- Normal 12-lead electrocardiogram
- Willing to refrain from using any local topical preparations
Exclusion Criteria:
- Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
- Known allergy or sensitivity to any component of the Synera patch, including
lidocaine, sympathomimetic amines, other local anesthetics of the amide type,
epinephrine, or other patch components
- Had an active dermatological disease of any origin that may have interfered with their
ability to participate
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