The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are: * Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration? * Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.
This Pilot Randomized Double Blind Clinical Trial study will assess the effectiveness of patient-applied aqueous lidocaine via tampon as a pre-treatment prior to intra-uterine device placement. Subjects will apply the lidocaine or a saline placebo to the end of a standard tampon with a plastic applicator and then place the tampon 1 hour prior to the procedure. The tampon will be removed as the subject prepares for the procedure. The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure. This data will be evaluated to compare the lidocaine to the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
4% aqueous solution
Tampon with plastic applicator provided
University Family Health Center, USUHS
Bethesda, Maryland, United States
Procedure time
Time from uterine sounding to cutting strings (to allow for procedures where an IUD is removed prior to placing a new IUD)
Time frame: Measured during procedure
Patient-reported pain level
0-10 Visual analog scale
Time frame: Obtained immediately after the procedure prior to the patient leaving the clinic
Patient-reported satisfaction with procedure
0 - 100%
Time frame: Obtained immediately after the procedure prior to the patient leaving the clinic
Patient-reported interest in subsequent procedure
Likert scale
Time frame: Obtained immediately after the procedure prior to the patient leaving the clinic
Provider-reported procedural difficulty
Likert scale
Time frame: Obtained immediately after the procedure prior to the patient leaving the clinic
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