In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction? (Synera patch)

The University of Texas System (UT)

Status and phase: Unknown; Phase 4

Conditions: Pain on Propofol IV Injection

Treatments: Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01); Drug: Gebauer's Ethyl Chloride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01576770

HSC-MS-12-0042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

ethyl chloride vapocoolant spray

Active Comparator group

Description:

Half of the patients will randomly be assigned to receive Gebauer's ethyl choride topical anesthetic vapo-coolant spray immediately prior to placing a 22 gauge intravenous catheter. Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4. Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the ethyl chloride or the patch.

Treatment:

Drug: Gebauer's Ethyl Chloride

Synera Patch

Experimental group

Description:

The other half of the patients will randomly be assigned to receive Synera Patches, to be applied to the dorsum of both hands, at least 30 minutes before placing a 22 gauge intravenous catheter. Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4. Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the patch or ethyl chloride.

Treatment:

Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01)