Clinical trial NCT01744197: Synera Venipuncture Pain
Official title: Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Phlebotomy
Palliative Care
Keywords: Pain control
Needle stick pain
Venipuncture pain
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Nuvo Research Inc.
First posted: 2012-12-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients With No or Minor Pain (VAS<3)
timeFrame: 30 minutes after the venipuncture.
measure: Percentage of Patients With No Pain (VAS=0)
timeFrame: 30 minutes after the venipuncture.
Secondary outcomes:
measure: Global Assessment of Satisfaction With Venipuncture
timeFrame: 30 minutes after the venipuncture.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: 19 Locations Including
state: Texas
Study officials:
affiliation: US Oncology Research, McKesson Specialty Health
name: Melanie Matson, RN, BSN
role: PRINCIPAL_INVESTIGATOR
affiliation: US Oncology Research, McKesson Specialty Health
name: Laura T. Guerra, RN
role: PRINCIPAL_INVESTIGATOR
References:
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;35(6):507-13. doi: 10.1097/AAP.0b013e3181fa69b8.
citation: 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/bja/aen364.