Phase 2
N=61
Synera Venipuncture Pain
Pain · Phlebotomy · Palliative Care
Bottom Line
View on ClinicalTrials.gov: NCT01744197 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Patients With No or Minor Pain (VAS<3) — 38.0; 21.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Synera (lidocaine 70mg/tetracaine 70mg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Oncology Research
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With No or Minor Pain (VAS<3) |
38.0; 21.3 | — |
| PRIMARY Percentage of Patients With No Pain (VAS=0) |
19.4; 8.3 | — |
| SECONDARY Global Assessment of Satisfaction With Venipuncture |
74.0; 53.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01744197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.