Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-06
First Post:
2023-02-23
Brief Title:
Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
Sponsor:
Uniformed Services University of the Health Sciences
Organization:
Uniformed Services University of the Health Sciences
Study Overview
Official Title:
Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAP-AID
Brief Summary:
The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion The main question it aims to answer are
Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device IUD reduce procedural duration
Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device IUD reduce pain and improve patient perceptions of the procedure Participants will place a tampon after dipping the tampon into the study-supplied medication aqueous lidocaine or saline Researchers will compare treatment and control groups to see if there is any difference in procedure time difficulty or patient perceptions
Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device IUD reduce procedural duration
Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device IUD reduce pain and improve patient perceptions of the procedure Participants will place a tampon after dipping the tampon into the study-supplied medication aqueous lidocaine or saline Researchers will compare treatment and control groups to see if there is any difference in procedure time difficulty or patient perceptions
Detailed Description:
This Pilot Randomized Double Blind Clinical Trial study will assess the effectiveness of patient-applied aqueous lidocaine via tampon as a pre-treatment prior to intra-uterine device placement Subjects will apply the lidocaine or a saline placebo to the end of a standard tampon with a plastic applicator and then place the tampon 1 hour prior to the procedure The tampon will be removed as the subject prepares for the procedure
The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure This data will be evaluated to compare the lidocaine to the control group
The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure This data will be evaluated to compare the lidocaine to the control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None