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Lidocaine Patches Prior to Intravenous Insertion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adam Singer, Stony Brook University
ClinicalTrials.gov Identifier:
NCT00552695
First received: October 31, 2007
Last updated: October 19, 2012
Last verified: October 2012

October 31, 2007
October 19, 2012
August 2007
January 2008   (final data collection date for primary outcome measure)
Pain on Visual Analog Scale (VAS) [ Time Frame: 0 MINUTES ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Success of Intravenous (IV) Insertion [ Time Frame: After first attempt of catheter insertion ] [ Designated as safety issue: No ]
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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
Both
3 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00552695
20076689
No
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