NCT05890495

Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Uniformed Services University of the Health Sciences · Federal
• Sex: Female
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Lidocaine topical	4% aqueous solution
DEVICE	Tampon	Tampon with plastic applicator provided

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2023-06-06
• Last updated: 2023-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study