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Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

NCT05890495 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-06-06

No results posted yet for this study

Summary

The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are:

* Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration?
* Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.

Conditions

  • Contraception

Interventions

DRUG

Lidocaine topical

4% aqueous solution

DEVICE

Tampon

Tampon with plastic applicator provided

Sponsors & Collaborators

  • American Academy of Family Physicians National Research Network

    collaborator NETWORK

  • Uniformed Services University of the Health Sciences

    lead FED

Principal Investigators

  • Michael J Arnold, MD · Associate Professor, Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-12-31
Completion
2024-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05890495 on ClinicalTrials.gov