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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 31, 2007

Last Updated Date

October 19, 2012

Start Date ^ICMJE

August 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Visual analog pain scale [ Time Frame: 30 minutes ]

Change History

Complete list of historical versions of study NCT00552695 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Success of IV insertion [ Time Frame: 30 minutes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lidocaine Patches Prior to Intravenous Insertion

Official Title ^ICMJE

Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Need for Intravenous Catheter

Intervention ^ICMJE

Device: Lidocaine tetracaine
Lidocaine 70 mg/tetracaine 70 mg

Other Name: Synera
Device: Placebo
Placebo patch identical in appearance to Synera

Study Arm (s)

Active Comparator: 1
Lidocaine 70 mg/tetracaine 70 mg skin patch

Intervention: Device: Lidocaine tetracaine
Placebo Comparator: 2
Intervention: Device: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Unstable patients,
Allergy to lidocaine or tetracaine

Gender

Both

Ages

3 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00552695

Other Study ID Numbers ^ICMJE

20076689

Has Data Monitoring Committee

Responsible Party

Adam Singer, Stony Brook University

Study Sponsor ^ICMJE

Stony Brook University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Adam J Singer, MD

Stony Brook University

Information Provided By

Stony Brook University

Verification Date

October 2012

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

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