Pain During Intrauterine Device Insertion
Conditions
Keywords
pain, intrauterine device, prilocaine-lidocaine, lidocaine, contraception
Brief summary
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.
Detailed description
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.
Interventions
Participants in this arm will receive prilocaine lidocaine cream to their cervix (4 grams) to their cervix 5 minutes prior to the procedure.
Participants will receive 1% lidocaine injected into the cervix (10mls) 5 minutes prior to the procedure
Sponsors
Study design
Eligibility
Inclusion criteria
* Nulliparous, parous female or non operative trans male * Participants want to have an IUD for contraception * Able to provide consent * Participants are between the ages of 18-45 years old * Individuals must meet the medical eligibility criteria for an IUD
Exclusion criteria
* pregnant or if pregnancy can not be ruled out the day of insertion * have abnormal uterine bleeding that has not been investigated * Lupus * liver disease * progesterone sensitive tumors * molar pregnancy * gynecological malignancy * breast cancer * clotting disorders * uterine anomalies * septic abortion within last three months * allergy to progesterone or copper * pelvic inflammatory disease * acute malignancies affecting blood * bacterial endocarditis * methemoglobinemia * allergy to prilocaine-lidocaine cream * actively breastfeeding * Participants taking beta-blockers and/ or antiarrhythmic drugs * Individuals who have taken opioids or benzodiazepines within 24 hours prior to the procedure * Participants who are currently using an IUD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | Baseline to end of treatment on day 1 | Zero is equivalent to no pain and 10 indicates the worst possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| State Trait Anxiety Inventory | Baseline | Participants will answer a questionnaire on their level of anxiety. |
| McGill Pain Questionnaire | end of treatment on day 1 | Participants will describe the pain/ if any they experienced during the procedure |
| Ease of Insertion | end of treatment on day 1 | Clinicians inserting the intrauterine device will rate on a numerical scale the difficulty of inserting the device, zero being extremely easy and ten being extremely difficult. |
| Non Pharmacological Measures | end of treatment on day 1 | Participants will answer a questionnaire on the type of nonpharmacological measures they used during the procedure |
| Adverse Reactions | at day 2 | Participants will answer a questionnaire about any adverse reactions they may have experienced. |
Countries
Canada
Contacts
Queen's University