Lidocaine-Prilocaine Cream as Analgesic for Outpatient Gynecological Procedures; A Randomized-Control Trial
Overview
- Phase
- Phase 4
- Intervention
- EMLA Cream
- Conditions
- Pain
- Sponsor
- CAMC Health System
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale Pain Score 3
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
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.
Detailed Description
Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy and endometrial biopsies (EMB) have no standard of care for pain management. This has resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this study is to evaluate whether EMLA cream reduces pain during the following outpatient procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. Pain scores will be compared between the study and placebo group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies
Exclusion Criteria
- •Known hypersensitivity to amide anesthetics
- •Pre-existing methemoglobinemia
Arms & Interventions
EMLA Cream
5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
Intervention: EMLA Cream
VersaPro Cream
5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
Intervention: VersaPro Cream Base for Compounding
Outcomes
Primary Outcomes
Visual Analogue Scale Pain Score 3
Time Frame: 2 minutes after speculum removal
Scale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 1
Time Frame: At time of speculum placement for procedure
Scale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 2
Time Frame: At start of cervical manipulation
Scale of 0-10 on a self-reported pain score