Pain, Palliative Care, Phlebotomy
Conditions
Keywords
Pain control, Needle stick pain, Venipuncture pain
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
Interventions
DRUGSynera (lidocaine 70mg/tetracaine 70mg)
All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.
Sponsors
Nuvo Research Inc.
US Oncology Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With No or Minor Pain (VAS<3) | 30 minutes after the venipuncture. | 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. |
| Percentage of Patients With No Pain (VAS=0) | 30 minutes after the venipuncture. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Satisfaction With Venipuncture | 30 minutes after the venipuncture. | Rates of Satisfied and very satisfied are used to be compared between two groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Synera First, Then Placebo Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after). | 32 |
| Placebo First, Then Synera Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after). | 29 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No patch received | 2 | 2 |
| Overall Study | Received 1 patch | 2 | 1 |
Baseline characteristics
| Characteristic | Synera First, Then Placebo | Placebo First, Then Synera | Total |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 11.2 | 60.3 years STANDARD_DEVIATION 13 | 60.5 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized African American | 1 participants | 4 participants | 5 participants |
| Race/Ethnicity, Customized Caucasian | 31 participants | 24 participants | 55 participants |
| Race/Ethnicity, Customized Indian | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 32 participants | 29 participants | 61 participants |
| Sex: Female, Male Female | 20 Participants | 14 Participants | 34 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 54 | 18 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 |
Outcome results
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.
Time frame: 30 minutes after the venipuncture.
Population: Normal completion patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synera | Percentage of Patients With No or Minor Pain (VAS<3) | 38.0 percentage of participants |
| Placebo | Percentage of Patients With No or Minor Pain (VAS<3) | 21.3 percentage of participants |
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.
Time frame: 30 minutes after the venipuncture.
Population: Normal completion patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synera | Percentage of Patients With No Pain (VAS=0) | 19.4 percentage of participants |
| Placebo | Percentage of Patients With No Pain (VAS=0) | 8.3 percentage of participants |
Secondary
Global Assessment of Satisfaction With Venipuncture
Rates of Satisfied and very satisfied are used to be compared between two groups.
Time frame: 30 minutes after the venipuncture.
Population: Normal completion patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synera | Global Assessment of Satisfaction With Venipuncture | 74.0 percentage of participants |
| Placebo | Global Assessment of Satisfaction With Venipuncture | 53.7 percentage of participants |