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The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine | Active Comparator | 1% lidocaine intradermal injection |
|
| bacteriostatic normal saline (BNS) | Active Comparator | bacteriostatic normal saline (BNS) injection |
|
| no local anesthetic | No Intervention | usual care practice of no local anesthetic administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% lidocaine | Drug |
| ||
| bacteriostatic normal saline (BNS) |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Patients' Perceptions of Pain Between Treatment Methods | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion. | at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Aucoin, DNS, RN | Duke Health | Principal Investigator |
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99 subjects consented in the study. 1 subject withdrawn from study by PI, therefore 98 subjects completed study.
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| ID | Title | Description |
|---|---|---|
| FG000 | no Local Anesthetic | usual care practice of no local anesthetic administration |
| FG001 | Lidocaine | 1% lidocaine intradermal injection 1% lidocaine |
| FG002 | Bacteriostatic Normal Saline (BNS) | bacteriostatic normal saline (BNS) injection bacteriostatic normal saline (BNS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | no Local Anesthetic | usual care practice of no local anesthetic administration |
| BG001 | Lidocaine | 1% lidocaine intradermal injection 1% lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differences in Patients' Perceptions of Pain Between Treatment Methods | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion. | Posted | Mean | Standard Deviation | units on a scale | at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute |
|
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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 | no Local Anesthetic | usual care practice of no local anesthetic administration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Aucoin, DNS | Duke University Medical Center | 1 919 613 6406 | julia.aucoin@dm.duke.edu |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| BG002 | Bacteriostatic Normal Saline (BNS) | bacteriostatic normal saline (BNS) injection bacteriostatic normal saline (BNS) |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Bacteriostatic Normal Saline (BNS) | bacteriostatic normal saline (BNS) injection bacteriostatic normal saline (BNS) |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Lidocaine | 1% lidocaine intradermal injection 1% lidocaine | 0 | 33 | 0 | 33 |
| EG002 | Bacteriostatic Normal Saline (BNS) | bacteriostatic normal saline (BNS) injection bacteriostatic normal saline (BNS) | 0 | 32 | 0 | 32 |
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| Aniline Compounds |
| D000588 | Amines |