Synera Venipuncture Pain
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2018 |
| Start Date: | January 2013 |
| End Date: | November 2013 |
Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures
Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended
to reduce the pain associated with venipuncture and superficial dermatologic procedures by
numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine
patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology
patients undergoing venipuncture as part of their care, for treatment or diagnostics
(laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes
that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30
minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS
to reduce the pain associated with venipuncture and superficial dermatologic procedures by
numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine
patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology
patients undergoing venipuncture as part of their care, for treatment or diagnostics
(laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes
that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30
minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS
Inclusion Criteria:
- Patients with any tumor type where treatment is received through venipuncture or any
procedure that is needle based or who require regular pharmacokinetic (PK) study.
- Is 18 years of age or older.
- Patients expected to undergo the first venipuncture procedure within 5 working days of
enrollment.
- Male or female patients
- Has signed the most recent Patient Informed Consent Form
- Has signed a Patient Authorization Form (HIPPA)
Exclusion Criteria:
- Patients with sensitivity to lidocaine, tetracaine, or any other component of the
product
- Known sensitivity to any components of test materials (sulphites and adhesives)
- Patients with damaged or broken skin at the designated patch site
- Pregnant or breastfeeding women patients
- Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone,
hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products
containing acetaminophen or ibuprofen with one of these agents within 4 hours of the
patient's visit
- Previous irradiation to the site of the patch
We found this trial at
1
site
