EMLA Cream as Analgesic for Outpatient Gynecological Procedures

NCT05970354 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 22-910
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

intra-uterine device insertion; hysteroscopy; endometrial biopsy

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale Pain Score 1

  Scale of 0-10 on a self-reported pain score

  At time of speculum placement for procedure

• Visual Analogue Scale Pain Score 2

  Scale of 0-10 on a self-reported pain score

  At start of cervical manipulation

• Visual Analogue Scale Pain Score 3

  Scale of 0-10 on a self-reported pain score

  2 minutes after speculum removal

Study Arms (2)

EMLA Cream

ACTIVE COMPARATOR

5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

Drug: EMLA Cream

VersaPro Cream

PLACEBO COMPARATOR

5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

Drug: VersaPro Cream Base for Compounding

Interventions

EMLA Cream DRUG

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

EMLA Cream

VersaPro Cream Base for Compounding DRUG

Placebo

VersaPro Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies

You may not qualify if:

• Known hypersensitivity to amide anesthetics
• Pre-existing methemoglobinemia

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Charleston Area Medical Center Institute for Academic Medicine

Charleston, West Virginia, 25302, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Alex Poulsen, DO

  West Virginia School of Medicine--Charleston Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 1, 2023
• Study Start: September 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

US (1)