Applying a New Method for Pain Control in Intrauterine Device Insertion

NCT06951191 Phase 4 TERMINATED

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

Details

Lead sponsor	University of Missouri-Columbia
Phase	Phase 4
Status	TERMINATED
Enrolment	1
Start date	2025-06-23
Completion	2026-04-15

Conditions

• IUD Insertion Pain
• IUD Insertion

Interventions

• Benzocaine 20%
• Lidocaine 2%
• Sham injection
• Saline 0.9%

Primary outcomes

• Mean Pain Score During IUD Insertion Events as Quantified by Visual Analogue Scale — During IUD insertion procedure
  The Visual Analogue Scale (VAS) is a 0-10 pain intensity scale commonly used to assess pain intensity. Scores of 0 represent having no pain at all while scores of 10 represent worst pain possible; Therefore higher scores represent worse outcomes for pain management. VAS will be used to determine participant's levels of experienced pain at the 5 distinct events (tenaculum placement, uterine sounding, IUD insertion/deployment, immediately after instrumentation removal, 15 minutes post-procedure).

Countries

United States