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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at start of cervical manipulation
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 minutes after speculum removal
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 minutes after speculum removal
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Analogue Scale Pain Score 1
Visual Analogue Scale Pain Score 2
Visual Analogue Scale Pain Score 3
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
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Who is running the clinical trial?
CAMC Health SystemLead Sponsor
45 Previous Clinical Trials
7,666 Total Patients Enrolled
1 Trials studying Pain
210 Patients Enrolled for Pain
Alex Poulsen, DOPrincipal InvestigatorWest Virginia School of Medicine--Charleston Division
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to certain types of anesthesia called amide anesthetics.I have a condition that affects my blood's oxygen-carrying capacity.I am scheduled for a procedure related to my uterus, such as IUD insertion, hysteroscopy, or an endometrial biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: VersaPro Cream
- Group 2: EMLA Cream
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients being accepted in this clinical trial presently?
"Clinicaltrials.gov confirms that this research endeavour, first posted on August 1st 2023 and last edited on July 24th 2023 is no longer recruiting patients. However, there are 370 other active studies searching for volunteers at present."
Answered by AI
Could you provide insight regarding EMLA Cream's possible adverse effects?
"There is enough evidence to affirm the safety of EMLA Cream, resulting in an assessment score of 3. This product has been approved for use after successful completion of its Phase 4 trial."
Answered by AI
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