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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Lidocaine 70 mg/tetracaine 70 mg skin patch |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine tetracaine | Device | Lidocaine 70 mg/tetracaine 70 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain on Visual Analog Scale (VAS) | Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain). | 0 MINUTES |
| Measure | Description | Time Frame |
|---|---|---|
| Success of Intravenous (IV) Insertion | Percentage of patients in whom intravenous catheter was inserted successfully | After first attempt of catheter insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam J Singer, MD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LIDODERM Patch | Lidocaine 70 mg/tetracaine 70 mg skin patch |
| FG001 | Control Patch | Warm patch with no active substances |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LIDODERM Patch | Lidocaine 70 mg/tetracaine 70 mg skin patch |
| BG001 | Control Patch | Warm patch with no active substances |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Success of Intravenous (IV) Insertion | Percentage of patients in whom intravenous catheter was inserted successfully | Posted | Number | Percentage of participants | After first attempt of catheter insertion |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LIDODERM Patch | Lidocaine 70 mg/tetracaine 70 mg skin patch |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Singer | Stony Brook U | 631-444-7857 | adam.singer@stonybrook.edu |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| Placebo | Device | Placebo patch identical in appearance to Synera |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
| Primary | Pain on Visual Analog Scale (VAS) | Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain). | Posted | Median | Inter-Quartile Range | mm | 0 MINUTES |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control Patch | Warm patch with no active substances | 0 | 23 | 0 | 23 |
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| D012816 | Signs and Symptoms |