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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04467125
Other study ID # 1288589-4
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 6, 2020
Est. completion date May 31, 2023

Study information

Verified date July 2020
Source Augusta University
Contact Manish Jain, MD
Phone 706-721-2542
Email majain@augusta.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Eutectic 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.
Subcutaneous 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.

Locations

Country Name City State
United States Augusta University Ob/Gyn Resident Continuity Clinic Augusta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain of procedure Using the pain scale the participant is asked to circle the numerical value of pain they had during removal. during procedure
Primary time to perform procedure the medical assistant times the procedure from incision to removal of the device. procedure
Secondary How likely to recommend their anesthetic? procedure
Secondary Provider's sense of ease of removal? procedure
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