In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction?
NCT ID: NCT01576770
Last Updated: 2012-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2012-04-30
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
lidocaine/tetracaine transdermal patch (NDC 43469-864-01)
70 mg lidocaine / 70 mg tetracaine
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Allergy to lidocaine or tetracaine
6 Years
17 Years
ALL
No
Sponsors
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ZARS Pharma Inc.
INDUSTRY
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Samia Khalil
Professor of Pediatric Anesthesia
Principal Investigators
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Samia N Khalil, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Sciences Center at Houston
Locations
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Memorial Herman Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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HSC-MS-12-0042
Identifier Type: -
Identifier Source: org_study_id
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