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Lidocaine Patches Prior to Intravenous Insertion

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ClinicalTrials.gov Identifier: NCT00552695
Recruitment Status : Completed
First Posted : November 2, 2007
Results First Posted : December 6, 2010
Last Update Posted : October 22, 2012
Information provided by (Responsible Party):
Adam Singer, Stony Brook University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Need for Intravenous Catheter
Interventions: Device: Lidocaine tetracaine
Device: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
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] 
[1] August 2007
[2] September 2007

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 22   23   45 
[Units: Participants]
<=18 years   22   23   45 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 9.3  (4.3)   10.8  (4.5)   10  (4.3) 
[Units: Participants]
Female   9   10   19 
Male   13   13   26 
Region of Enrollment 
[Units: Participants]
United States   22   23   45 

  Outcome Measures

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

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

  Serious Adverse Events

  Other Adverse Events

  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
No text entered.

  More Information

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.

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

Responsible Party: Adam Singer, Stony Brook University
ClinicalTrials.gov Identifier: NCT00552695     History of Changes
Other Study ID Numbers: 20076689
First Submitted: October 31, 2007
First Posted: November 2, 2007
Results First Submitted: October 16, 2009
Results First Posted: December 6, 2010
Last Update Posted: October 22, 2012