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Recruiting Phase 4 NCT06951191

Intrauterine Device Insertion Pain Management

Trial Parameters

Condition IUD Insertion Pain
Sponsor University of Missouri-Columbia
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 160
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-06-23
Completion 2026-05
Interventions
Benzocaine 20%Lidocaine 2%Sham injection

Brief 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 Criteria

Inclusion Criteria: * 18 years of age or older * Undergoing IUD insertion Exclusion Criteria: * 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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