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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 Stony Brook University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Adam Singer, Research Director, Stony Brook University
ClinicalTrials.gov Identifier: NCT00552695     History of Changes
Other Study ID Numbers: 20076689
Study First Received: October 31, 2007
Results First Received: October 16, 2009
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014