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

Results First Received: October 16, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Treatment
Condition:	Need for Intravenous Catheter
Interventions:	Device: Lidocaine tetracaine Device: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
LIDODERM Patch	Lidocaine 70 mg/tetracaine 70 mg skin patch
Control Patch	Warm patch with no active substances

Participant Flow: Overall Study

	LIDODERM Patch	Control Patch
STARTED	22 ^[1]	23 ^[1]
COMPLETED	22 ^[2]	23 ^[2]
NOT COMPLETED	0	0

[1]	August 2007
[2]	September 2007

Baseline Characteristics

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Reporting Groups

	Description
LIDODERM Patch	Lidocaine 70 mg/tetracaine 70 mg skin patch
Control Patch	Warm patch with no active substances
Total	Total of all reporting groups

Baseline Measures

	LIDODERM Patch	Control Patch	Total
Number of Participants [units: participants]	22	23	45
Age [units: participants]
<=18 years	22	23	45
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	9.3 ± 4.3	10.8 ± 4.5	10 ± 4.3
Gender [units: participants]
Female	9	10	19
Male	13	13	26
Region of Enrollment [units: participants]
United States	22	23	45

Outcome Measures

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1. Primary:

Pain on Visual Analog Scale (VAS) [ Time Frame: 0 MINUTES ]

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2. Secondary:

Success of Intravenous (IV) Insertion [ Time Frame: After first attempt of catheter insertion ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Adam Singer
Organization: Stony Brook U
phone: 631-444-7857
e-mail: adam.singer@stonybrook.edu

No publications provided

Responsible Party:	Adam Singer, 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

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