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A randomized trial of using EMLA cream for anesthesia to remove Nexplanon versus the standard route of subcutaneous lidocaine for anesthesia. Primary endpoints are pain during procedure and time to removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMLA | Experimental | Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed. |
|
| Subcutaneous Lidocaine | Active Comparator | Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eutectic Lidocaine Prilocaine | Drug | Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed. |
| Measure | Description | Time Frame |
|---|---|---|
| pain of procedure | Using the pain scale the participant is asked to circle the numerical value of pain they had during removal. | during procedure |
| time to perform procedure | the medical assistant times the procedure from incision to removal of the device. | procedure |
| Measure | Description | Time Frame |
|---|---|---|
| How likely to recommend their anesthetic? | procedure | |
| Provider's sense of ease of removal? | procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manish Jain, MD | Contact | 706-721-2542 | majain@augusta.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University Ob/Gyn Resident Continuity Clinic | Recruiting | Augusta | Georgia | 30912 | United States |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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| Subcutaneous Lidocaine | Drug | Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected by the provider at the removal site in an amount decided on by the provider. |
|
| Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |