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Intrauterine Device Insertion Pain Management

Applying a New Method for Pain Control in Intrauterine Device Insertion

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06951191
Enrollment
160
Registered
2025-04-30
Start date
2025-06-23
Completion date
2026-12-31
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD Insertion Pain, IUD Insertion

Keywords

IUD, IUD insertion, IUD insertion pain, benzocaine, paracervical lidocaine, paracervical block

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

Detailed description

The goal of the researchers is to determine if use of a topical benzocaine spray prior to lidocaine injection will cause a significant reduction in pain experienced by patients undergoing an IUD insertion. Participants will be screened, approached, and fully consented by research staff in the clinic prior to their IUD insertion. Demographics will be gathered from all participants through a questionnaire. All participants will be given 600mg of ibuprofen prior to the procedure, but will be randomized into one of 4 groups as to what interventions/placebos they will receive during their insertion. Interventions studied are benzocaine spray and lidocaine injection. Placebos will be saline spray and paracervical needle stick without injection. Participants will be asked to rate their pain on a visual scale of 1-10 at the following timepoints during the procedure: * At the time of tenaculum placement * At the time of uterine sounding * At the time of IUD insertion and deployment * Immediately after removal of instrumentation * 15 minutes after the procedure Participants who provided an email will be sent an additional questionnaire to be responded to within 24 hours of the procedure. At the conclusion of the trial statistical analysis will be done to determine significance of pain reduction varying between the 4 groups.

Interventions

DRUGBenzocaine 20%

Benzocaine 20% topical spray

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

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Pain Score During IUD Insertion Events as Quantified by Visual Analogue ScaleDuring IUD insertion procedureThe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026