Pain Clinical Trial
Official title:
Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures
NCT number | NCT01744197 |
Other study ID # | 12112 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2013 |
Est. completion date | November 2013 |
Verified date | September 2018 |
Source | US Oncology Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 61 |
Est. completion date | November 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | 19 Locations Including | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
US Oncology Research | Nuvo Research Inc. |
United States,
Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (Synera, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009 Feb;102(2):210-5. doi: 10.1093/b — View Citation
Wallace MS, Kopecky EA, Ma T, Brophy F, Campbell JC. Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (Synera) patches compared with placebo patches applied to healthy adult volunteers. Reg Anesth Pain Med. 2010 Nov-Dec; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients With No or Minor Pain (VAS<3) | The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS <3 is considered as patients with no or minor pain and would be compared between 2 groups. | 30 minutes after the venipuncture. | |
Primary | Percentage of Patients With No Pain (VAS=0) | The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups. | 30 minutes after the venipuncture. | |
Secondary | Global Assessment of Satisfaction With Venipuncture | Rates of Satisfied and very satisfied are used to be compared between two groups. | 30 minutes after the venipuncture. |
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