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Lidocaine Patches Prior to Intravenous Insertion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552695
First Posted: November 2, 2007
Last Update Posted: October 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adam Singer, Stony Brook University
  Purpose
This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.

Condition Intervention Phase
Need for Intravenous Catheter Device: Lidocaine tetracaine Device: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.

Resource links provided by NLM:


Further study details as provided by Adam Singer, Stony Brook University:

Primary Outcome Measures:
  • Pain on Visual Analog Scale (VAS) [ Time Frame: 0 MINUTES ]
    Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).


Secondary Outcome Measures:
  • Success of Intravenous (IV) Insertion [ Time Frame: After first attempt of catheter insertion ]
    Percentage of patients in whom intravenous catheter was inserted successfully


Enrollment: 45
Study Start Date: August 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Lidocaine 70 mg/tetracaine 70 mg skin patch
Device: Lidocaine tetracaine
Lidocaine 70 mg/tetracaine 70 mg
Other Name: Synera
Placebo Comparator: 2 Device: Placebo
Placebo patch identical in appearance to Synera

Detailed Description:
Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 3,
  • Need for non-emergent intravenous catheter

Exclusion Criteria:

  • Unstable patients,
  • Allergy to lidocaine or tetracaine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552695


Locations
United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Adam J Singer, MD Stony Brook University
  More Information

Responsible Party: Adam Singer, Research Director, Stony Brook University
ClinicalTrials.gov Identifier: NCT00552695     History of Changes
Other Study ID Numbers: 20076689
First Submitted: October 31, 2007
First Posted: November 2, 2007
Results First Submitted: October 16, 2009
Results First Posted: December 6, 2010
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by Adam Singer, Stony Brook University:
intravenous catheter
emergency department
pain

Additional relevant MeSH terms:
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action