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EMLA Cream as Analgesic for Outpatient Gynecological Procedures

NCT05970354 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-08-01

No results posted yet for this study

Summary

The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is:

• Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy?

Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.

Conditions

Interventions

DRUG

EMLA Cream

Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)

DRUG

VersaPro Cream Base for Compounding

Placebo

Sponsors & Collaborators

  • CAMC Health System

    lead OTHER

Principal Investigators

  • Alex Poulsen, DO · West Virginia School of Medicine--Charleston Division

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-12-31
Completion
2025-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05970354 on ClinicalTrials.gov