Contraception
Conditions
Brief summary
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.
Interventions
DRUGEutectic Lidocaine Prilocaine
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.
DRUGSubcutaneous Lidocaine
Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected by the provider at the removal site in an amount decided on by the provider.
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Females with Nexplanon implant in place, desiring removal No allergy to lidocaine or any component of EMLA cream Age greater than or equal to 18years English as primary language Not pregnant
Exclusion criteria
* pregnant non-emglish speaking age less than 18 yo Allergy to lidocaine or EMLA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain of procedure | during procedure | Using the pain scale the participant is asked to circle the numerical value of pain they had during removal. |
| time to perform procedure | procedure | the medical assistant times the procedure from incision to removal of the device. |
Secondary
| Measure | Time frame |
|---|---|
| How likely to recommend their anesthetic? | procedure |
| Provider's sense of ease of removal? | procedure |
Countries
United States
Contacts
Primary ContactManish Jain, MD
Outcome results
None listed