The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device Insertion

Overview

The goal of this clinical trial is to learn if two pain medications used to treat pain during intrauterine device insertions work in persons with a uterus. It will also learn about the safety of the two study medications. The main questions it aims to answer are: Does prilocaine lidocaine, acetaminophen and naproxen or lidocaine injection, acetaminophen and naproxen reduce pain during intrauterine device insertions. Researchers will compare prilocaine lidocaine cream and lidocaine injection to see if it treats pain during an intrauterine device insertion. Participants will be asked to: * take acetaminophen and naproxen prior to the procedure. * receive either prilocaine-lidocaine or lidocaine injection during the procedure * to fill out a survey on past medical history, anxiety, and pain.

Intrauterine devices (IUDs) are one of the most recommended forms of birth control. An IUD is a small device placed inside the uterus to prevent pregnancy. Many individuals prefer the IUD as it does not require taking a pill every day. These devices are typically inserted in the patient's nurse practitioner's or physician's clinic. Intrauterine devices are very effective in preventing an unwanted pregnancy; however, the procedure can be painful. Without medication, individuals have described the pain as moderate to severe. Pain and the fear of experiencing pain are one reason why individuals choose not to get an IUD and choose less effective birth control. There are several pain relief options to help alleviate pain during IUD insertions, such as acetaminophen, naproxen, and local freezing medications. The local medications can be given as a cream or an injection. Unfortunately, not all health care providers offer pain relief options, and there is no consensus on which is the most effective. This study aims to use multiple pain relief options and compare the cream and the injectable medication to see which combination is more effective. A total of 66 participants will take part in this study. Each participant will be randomly assigned to one of the pain management groups: anesthetic cream or injection. Before the procedure, participants will answer a questionnaire about their general health, demographics, and anxiety. Participants will be given acetaminophen and naproxen 45 minutes before the start of the procedure. During the procedure, participants will be asked to rate their pain on a scale of 0 to 10. After the procedure, participants will be asked to describe the pain they experienced. The acute care pain guidelines recommend the use of multiple medications and the use of non-pharmacological methods such as distraction for pain relief. Prior studies have focused on one pain relief option for pain during IUD insertions. In addition, no prior study has compared the analgesic cream against the injectable analgesic. Conducting this study will aid in a clearer understanding of which pain relief measure is appropriate to use during IUD insertions. If both pain relief options are equally effective, then individuals will have a choice between the use of a cream or an injection for pain relief; the latter of which can also inflict pain. The results of this study will be shared at conferences across the country and through scientific journals. The results will facilitate conversations among health care providers about appropriate pain management. Patients can use this information to advocate for improved pain relief during their procedures, thereby empowering persons with a cervix during gynecological procedures. The research team is largely made up of women who are nurses or nurse practitioners, a field that is predominantly female. This study will contribute to the growth of nurse-led research in women's reproductive health and can be used to inform decision-making and policy changes for improved pain control in women's reproductive health.