Recruiting

Synera Patch

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT01576770

Conditions

Pain on Propofol IV Injection

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

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

Gebauer's Ethyl Chloride

Study Details

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.

Conditions

Pain on Propofol IV Injection

Study ID

NCT01576770

Start date

Apr, 2012

Status verified date

Apr, 2012

Completion date

Jan, 2013

Anticipated

Primary completion date

Oct, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

70 mg lidocaine / 70 mg tetracaine

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Samia N Khalil, M.D.

713.500.6242samia.n.khalil@uth.tmc.edu

Mohammed Ali, M.D.

713.500.6194mohammed.ali@uth.tmc.edu

Locations

Memorial Herman Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 12, 2012

Last verified

Apr, 2012

Keywords

  • propofol
  • Pain
  • Synera Patch
  • Gebauer's Ethyl Chloride topical anesthetic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2012-04-12.