RecruitingPhase 4NCT06951191

Intrauterine Device Insertion Pain Management

Applying a New Method for Pain Control in Intrauterine Device Insertion


Sponsor

University of Missouri-Columbia

Enrollment

160 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • years of age or older
  • Undergoing IUD insertion

Exclusion Criteria6

  • IUD insertion \<6 weeks postpartum
  • Age \<18 years
  • Allergy or history of adverse effect of lidocaine, benzocaine (and inactive ingredients: flavor, isobutane, propane, polyethylene glycol, sodium saccharin), or ibuprofen
  • Not undergoing IUD insertion
  • Undergoing IUD insertion under general anesthesia
  • Usage of anti-inflammatory or as-needed anxiety medications (not daily use) in the 12 hours prior to IUD insertion

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Interventions

DRUGBenzocaine 20%

Benzocaine 20% topical spray

DRUGLidocaine 2%

Lidocaine 2% injectable solution

OTHERSham injection

Sham injection to mimic Lidocaine paracervical block. Will use an injection needle and sham inject (no actual injection of fluid)

DRUGSaline 0.9%

Saline spray to mimic use of benzocaine spray


Locations(1)

Missouri OB/GYN Associates-Smiley Lane

Columbia, Missouri, United States

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NCT06951191


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