MedTrace Logo

Intrauterine Device Insertion Pain Management

NCT06951191 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-04-21

No results posted yet for this study

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

Conditions

  • IUD Insertion Pain
  • IUD Insertion

Interventions

DRUG

Benzocaine 20%

Benzocaine 20% topical spray

DRUG

Lidocaine 2%

Lidocaine 2% injectable solution

OTHER

Sham injection

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

DRUG

Saline 0.9%

Saline spray to mimic use of benzocaine spray

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2026-04-15
Completion
2026-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951191 on ClinicalTrials.gov