Lidocaine Patches Prior to Intravenous Insertion

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. Identifier: NCT00552695
Recruitment Status : Completed
First Posted : November 2, 2007
Results First Posted : December 6, 2010
Last Update Posted : October 22, 2012
Information provided by (Responsible Party):
Adam Singer, Stony Brook University

October 31, 2007
November 2, 2007
October 16, 2009
December 6, 2010
October 22, 2012
August 2007
January 2008   (Final data collection date for primary outcome measure)
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).
Visual analog pain scale [ Time Frame: 30 minutes ]
Complete list of historical versions of study NCT00552695 on Archive Site
Success of Intravenous (IV) Insertion [ Time Frame: After first attempt of catheter insertion ]
Percentage of patients in whom intravenous catheter was inserted successfully
Success of IV insertion [ Time Frame: 30 minutes ]
Not Provided
Not Provided
Lidocaine Patches Prior to Intravenous Insertion
Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Need for Intravenous Catheter
  • Device: Lidocaine tetracaine
    Lidocaine 70 mg/tetracaine 70 mg
    Other Name: Synera
  • Device: Placebo
    Placebo patch identical in appearance to Synera
  • Active Comparator: 1
    Lidocaine 70 mg/tetracaine 70 mg skin patch
    Intervention: Device: Lidocaine tetracaine
  • Placebo Comparator: 2
    Intervention: Device: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable patients,
  • Allergy to lidocaine or tetracaine
Sexes Eligible for Study: All
3 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Adam Singer, Stony Brook University
Stony Brook University
Not Provided
Principal Investigator: Adam J Singer, MD Stony Brook University
Stony Brook University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP