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

NCT01576770 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-04-12

No results posted yet for this study

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

Interventions

DEVICE

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

70 mg lidocaine / 70 mg tetracaine

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.

Sponsors & Collaborators

  • ZARS Pharma Inc.

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Samia N Khalil, M.D. · University of Texas Health Sciences Center at Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576770 on ClinicalTrials.gov