Pain on Propofol IV Injection
Conditions
Keywords
propofol, Pain, Synera Patch, Gebauer's Ethyl Chloride topical anesthetic
Brief summary
The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.
Detailed description
Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia. Propofol injection is associated with pain that can be severe. The investigators also place a lidocaine/tetracaine skin patch (Synera) to decrease pain associated with IV placement. Because the local anesthetics of the Synera patch diffuse deep underneath the skin, in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection. Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement. A total of 33 patients will be enrolled in each group.
Interventions
DEVICElidocaine/tetracaine transdermal patch (NDC 43469-864-01)
70 mg lidocaine / 70 mg tetracaine
Spray is to be applied topically to skin (dorsum of the hand for study purposes)until it turns white or for up to 10 seconds.
Sponsors
ZARS Pharma Inc.
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Healthy, outpatient children, 6-17 years old * American Society of Anesthesiologist Physical Classification rating of 1 or 2 * Elective procedure requiring general anesthesia at Memorial Herman Hospital, The Medical Center, Houston, Texas
Exclusion criteria
* Skin disease or infection (on dorsum of hands) * Allergy to lidocaine or tetracaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of children in each group who do not feel pain or have mild pain on propofol injection. | Within one hour, plus or minus one half hour | The primary outcome variable is the success/failure of therapy. The therapy is considered a success if a child feels no pain OR has mild pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Within one hour, plus or minus one half hour | A blinded independent observer and a blinded anesthesiologist will rate pain on propofol injection according to a pain scale: 1. \- no pain 2. \- mild pain (associated with facial expression of pain) 3. \- moderate pain (pulling/withdrawal of the arm) 4. \- severe pain (screaming) |
Countries
United States
Contacts
Primary ContactSamia N Khalil, M.D.
Backup ContactMohammed Ali, M.D.
Outcome results
None listed