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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZARS Pharma Inc.
Information provided by (Responsible Party):
Samia Khalil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01576770
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Pain on Propofol IV Injection
Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01)
Drug: Gebauer's Ethyl Chloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In Children, Does the Use of Synera Patch for Local Analgesia Before Vascular Access Reduce Pain Associated With Propofol Injection for Anesthesia Induction?

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Number of children in each group who do not feel pain or have mild pain on propofol injection. [ Time Frame: Within one hour, plus or minus one half hour ] [ Designated as safety issue: No ]
    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:
  • Pain intensity [ Time Frame: Within one hour, plus or minus one half hour ] [ Designated as safety issue: No ]

    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)


Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576770

Contacts
Contact: Samia N Khalil, M.D. 713.500.6242 samia.n.khalil@uth.tmc.edu
Contact: Mohammed Ali, M.D. 713.500.6194 mohammed.ali@uth.tmc.edu

Locations
United States, Texas
Memorial Herman Hospital Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
ZARS Pharma Inc.
Investigators
Principal Investigator: Samia N Khalil, M.D. University of Texas Health Sciences Center at Houston
  More Information

No publications provided

Responsible Party: Samia Khalil, Professor of Pediatric Anesthesia, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01576770     History of Changes
Other Study ID Numbers: HSC-MS-12-0042
Study First Received: April 10, 2012
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
propofol
Pain
Synera Patch
Gebauer's Ethyl Chloride topical anesthetic

Additional relevant MeSH terms:
Anesthetics
Tetracaine
Ethyl Chloride
Lidocaine
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 28, 2014