- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00552695
Lidocaine Patches Prior to Intravenous Insertion
October 19, 2012 updated by: Adam Singer, Stony Brook University
Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Stony Brook University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age greater than or equal to 3,
- Need for non-emergent intravenous catheter
Exclusion Criteria:
- Unstable patients,
- Allergy to lidocaine or tetracaine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
Placebo patch identical in appearance to Synera
|
Active Comparator: 1
Lidocaine 70 mg/tetracaine 70 mg skin patch
|
Lidocaine 70 mg/tetracaine 70 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on Visual Analog Scale (VAS)
Time Frame: 0 MINUTES
|
Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).
|
0 MINUTES
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of Intravenous (IV) Insertion
Time Frame: After first attempt of catheter insertion
|
Percentage of patients in whom intravenous catheter was inserted successfully
|
After first attempt of catheter insertion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam J Singer, MD, Stony Brook University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
October 31, 2007
First Submitted That Met QC Criteria
October 31, 2007
First Posted (Estimate)
November 2, 2007
Study Record Updates
Last Update Posted (Estimate)
October 22, 2012
Last Update Submitted That Met QC Criteria
October 19, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Tetracaine
Other Study ID Numbers
- 20076689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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