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
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
No text entered.

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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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
  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 ]

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


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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