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

In Children, Does the Use of Synera Patch for Local Analgesia Before Vascular Access Reduce Pain Associated With Propofol Injection for Anesthesia Induction?

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Herman Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ethyl chloride vapocoolant spray; 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.	Drug: Gebauer's Ethyl Chloride; 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.; Other Names: CHLOROETHANE, HYDROCHLORIC ETHER; NDC 45951-0123
EXPERIMENTAL: Synera Patch; 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.	Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01); 70 mg lidocaine / 70 mg tetracaine; Other Names: NDC 43469-864-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children in each group who do not feel pain or have mild pain on propofol injection.	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.	Within one hour, plus or minus one half hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	A blinded independent observer and a blinded anesthesiologist will rate pain on propofol injection according to a pain scale: - no pain; - mild pain (associated with facial expression of pain); - moderate pain (pulling/withdrawal of the arm); - severe pain (screaming)	Within one hour, plus or minus one half hour

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: ZARS Pharma Inc.
• Investigators: Principal Investigator: Samia N Khalil, M.D., University of Texas Health Sciences Center at Houston

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2012
• Study Completion (ANTICIPATED): January 1, 2013

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (ESTIMATE): April 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 12, 2012
• Last Update Submitted That Met QC Criteria: April 11, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Pain; propofol; Synera Patch; Gebauer's Ethyl Chloride topical anesthetic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Tetracaine; Ethyl Chloride
• Other Study ID Numbers: HSC-MS-12-0042