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

Phase 4

• Conditions: Pain on Propofol IV Injection
• Interventions: Drug: Gebauer's Ethyl Chloride; Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01)

• Registration Number: NCT01576770
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Status Verified: 2012-04
• Study Start: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Last Update Submitted: 2012-04-11
• Study First Posted: 2012-04-12
• Last Update Posted: 2012-04-12
• Primary Completion: 2012-10
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ethyl chloride vapocoolant spray	Gebauer's Ethyl Chloride	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.
Synera Patch	lidocaine/tetracaine transdermal patch (NDC 43469-864-01)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Memorial Herman Hospital; 🇺🇸 Houston, Texas, United States