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EMLA Cream for Pain Management During Gynecological Procedures

Phase 4
Waitlist Available
Led By Alex Poulsen, DO
Research Sponsored by CAMC Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Pre-existing methemoglobinemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at start of cervical manipulation
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will compare pain levels during gynecological procedures with EMLA cream vs placebo to determine if EMLA cream reduces pain. Participants will rate pain levels.

Who is the study for?
This trial is for patients undergoing certain gynecological procedures: IUD insertion, hysteroscopy, or endometrial biopsy. It's not suitable for those with allergies to amide anesthetics or who have a condition called methemoglobinemia.
What is being tested?
The study tests if EMLA Cream (a local anesthetic) reduces pain compared to a placebo during specific outpatient gynecological procedures. Participants will rate their pain at different times using the Visual Analogue Scale.
What are the potential side effects?
EMLA Cream may cause side effects such as skin irritation at the site of application and in rare cases could contribute to increased levels of methemoglobin in the blood which affects oxygen delivery.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition that affects my blood's oxygen-carrying capacity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 minutes after speculum removal
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 minutes after speculum removal for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Visual Analogue Scale Pain Score 1
Visual Analogue Scale Pain Score 2
Visual Analogue Scale Pain Score 3

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: EMLA CreamActive Control1 Intervention
5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
Group II: VersaPro CreamPlacebo Group1 Intervention
5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

Find a Location

Who is running the clinical trial?

CAMC Health SystemLead Sponsor
45 Previous Clinical Trials
7,596 Total Patients Enrolled
1 Trials studying Pain
210 Patients Enrolled for Pain
Alex Poulsen, DOPrincipal InvestigatorWest Virginia School of Medicine--Charleston Division

Media Library

EMLA Cream Clinical Trial Eligibility Overview. Trial Name: NCT05970354 — Phase 4
Pain Research Study Groups: VersaPro Cream, EMLA Cream
Pain Clinical Trial 2023: EMLA Cream Highlights & Side Effects. Trial Name: NCT05970354 — Phase 4
EMLA Cream 2023 Treatment Timeline for Medical Study. Trial Name: NCT05970354 — Phase 4
~0 spots leftby Dec 2024
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