NCT01576770

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

6 months

First QC Date

April 10, 2012

Last Update Submit

April 11, 2012

Conditions

Pain on Propofol IV Injection

Keywords

propofolPainSynera PatchGebauer's Ethyl Chloride topical anesthetic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain intensity

    Within one hour, plus or minus one half hour

Study Arms (2)

ethyl chloride vapocoolant spray

ACTIVE COMPARATOR

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

Synera Patch

EXPERIMENTAL

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)

Interventions

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

70 mg lidocaine / 70 mg tetracaine

Also known as: NDC 43469-864-01
Synera Patch
Gebauer's Ethyl ChlorideDRUG

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.

Also known as: CHLOROETHANE, HYDROCHLORIC ETHER, NDC 45951-0123
ethyl chloride vapocoolant spray

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Skin disease or infection (on dorsum of hands)
  • Allergy to lidocaine or tetracaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Herman Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Ethyl Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbonsOrganic Chemicals

Study Officials

  • Samia N Khalil, M.D.

    University of Texas Health Sciences Center at Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samia N Khalil, M.D.

CONTACT

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

Mohammed Ali, M.D.

CONTACT

713.500.6194mohammed.ali@uth.tmc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatric Anesthesia

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 12, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

US(1)