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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Lidocaine
Tetracaine
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014