Applying a New Method for Pain Control in Intrauterine Device Insertion

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to learn if use of topical benzocaine prior to the injection of lidocaine is effective in decreasing pain experienced during IUD insertion in patients 18 or older. The main question it aims to answer is: Does topical use of benzocaine prior to lidocaine injection during IUD insertion effectively decrease pain experienced? Researchers will compare benzocaine/lidocaine to benzocaine/placebo, placebo/lidocaine, and placebo/placebo to see if use of benzocaine prior to lidocaine injection works more effectively to decrease pain experienced rather than lidocaine, benzocaine, or placebo use alone. Participants will: * Arrive to clinic for previously scheduled IUD insertion * Be screened, approached by research staff, and consented to join the trial * Complete a demographic questionnaire * Be randomly and blindly assigned to one of four groups * Placebo/Placebo * Placebo/Lidocaine * Benzocaine/Placebo * Benzocaine/Lidocaine * All groups will be given 600mg of ibuprofen prior to procedure * Be asked to rate their pain on a visual scale of 1-10 during several distinct points of the procedure. * Be sent an optional survey to their email after the procedure

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 18 years of age or older

• Undergoing IUD insertion

Locations
United States
Missouri
Missouri OB/GYN Associates-Smiley Lane
RECRUITING
Columbia
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2026-12
Participants
Target number of participants: 160
Treatments
Placebo_comparator: Placebo/Placebo
Participants in this arm will receive saline spray and a needle stick without injection to the cervix
Experimental: Placebo/Lidocaine
Participants in this arm will receive saline spray and injected lidocaine to the cervix
Experimental: Benzocaine/Placebo
Participants in this arm will receive benzocaine spray and a needle stick without injection to the cervix
Experimental: Benzocaine/Lidocaine
Participants in this arm will receive benzocaine spray and lidocaine injection to the cervix
Related Therapeutic Areas
Sponsors
Leads: University of Missouri-Columbia

This content was sourced from clinicaltrials.gov