EMLA Cream as Analgesic for Outpatient Gynecological Procedures

Part of paid clinical trials in Charleston, West Virginia.

Sponsor
CAMC Health System
Study ID
NCT05970354
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • EMLA Cream — DRUG
    Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)
  • VersaPro Cream Base for Compounding — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: EMLA Cream
    5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
  • Placebo Comparator: VersaPro Cream
    5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

Primary Outcome Measure

Visual Analogue Scale Pain Score 1 [ Time Frame: At time of speculum placement for procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
Charleston Area Medical Center Institute for Academic MedicineCharlestonWest Virginia25302-

Find similar trials in Charleston, WV

By research site
Charleston Area Medical Center Institute for Academic Medicine· Charleston, WV

Related Studies