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| Name | Class |
|---|---|
| Queen's University, Kingston, Ontario | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prilocaine Lidocaine Arm | Active Comparator | Participants will received prilocaine lidocaine injection, acetaminophen and naproxen |
|
| Lidocaine injection | Active Comparator | Participants will receive lidocaine injection, acetaminophen and naproxen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prilocaine, Lidocaine | Drug | Participants in this arm will receive prilocaine lidocaine cream to their cervix (4 grams) to their cervix 5 minutes prior to the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale | Zero is equivalent to no pain and 10 indicates the worst possible pain | Baseline to end of treatment on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| State Trait Anxiety Inventory | Participants will answer a questionnaire on their level of anxiety. | Baseline |
| McGill Pain Questionnaire | Participants will describe the pain/ if any they experienced during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Information | Participants will answer a questionnaire about their current and past health. In addition, to sociodemographic information ( such as age, sex, gender) | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aprill D Susin, NP, PhD(c) | Contact | 19029890116 | aprill.susin@queensu.ca | |
| Monakshi Sawhney, NP, PhD | Contact | 14168160487 | mona.sawhney@queensu.ca |
| Name | Affiliation | Role |
|---|---|---|
| Monakshi Sawhney, NP, PhD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodlawn Medical Clinic | Dartmouth | Nova Scotia | B2W 2S7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41587631 | Background | Kirubarajan A, Gryn A, Werger M, Salim S, Ivanisevic S, Liu J, Wang S, Huszti E, Jacobson M, Flamer D, Spitzer RF, Sobel M. A double-blind, triple-arm randomized controlled trial of 1% lidocaine paracervical block for intrauterine device (IUD) insertion. Contraception. 2026 Aug;160:111393. doi: 10.1016/j.contraception.2026.111393. Epub 2026 Jan 24. | |
| 25946948 |
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No individual participant data will be shared with other researchers
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|
| Lidocaine HCl 1% | Drug | Participants will receive 1% lidocaine injected into the cervix (10mls) 5 minutes prior to the procedure |
|
|
| end of treatment on day 1 |
| Ease of Insertion | 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. | end of treatment on day 1 |
| Non Pharmacological Measures | Participants will answer a questionnaire on the type of nonpharmacological measures they used during the procedure | end of treatment on day 1 |
| Adverse Reactions | Participants will answer a questionnaire about any adverse reactions they may have experienced. | at day 2 |
| Tavakolian S, Doulabi MA, Baghban AA, Mortazavi A, Ghorbani M. Lidocaine-Prilocaine Cream as Analgesia for IUD Insertion: A Prospective, Randomized, Controlled, Triple Blinded Study. Glob J Health Sci. 2015 Jan 27;7(4):399-404. doi: 10.5539/gjhs.v7n4p399. |
| 30611553 | Background | Samy A, Abbas AM, Mahmoud M, Taher A, Awad MH, El Husseiny T, Hussein M, Ramadan M, Shalaby MA, El Sharkawy M, Hatem D, Alaa-El-Din Wali A, Abd-El-Fatah SM, Hussein AH, Haggag H. Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis. Fertil Steril. 2019 Mar;111(3):553-561.e4. doi: 10.1016/j.fertnstert.2018.11.012. Epub 2019 Jan 2. |
| 31882291 | Background | Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25. |
| 28503818 | Background | Karasu Y, Comert DK, Karadag B, Ergun Y. Lidocaine for pain control during intrauterine device insertion. J Obstet Gynaecol Res. 2017 Jun;43(6):1061-1066. doi: 10.1111/jog.13308. Epub 2017 May 15. |
| 30095776 | Background | Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790. |
| 36961099 | Background | Lopes-Garcia EA, Carmona EV, Monteiro I, Bahamondes L. Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery. Eur J Contracept Reprod Health Care. 2023 Jun;28(3):163-167. doi: 10.1080/13625187.2023.2189500. Epub 2023 Mar 24. |
| 31563628 | Background | Hunter TA, Sonalkar S, Schreiber CA, Perriera LK, Sammel MD, Akers AY. Anticipated Pain During Intrauterine Device Insertion. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):27-32. doi: 10.1016/j.jpag.2019.09.007. Epub 2019 Sep 26. |
| 22588748 | Background | Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| 34715839 | Background | de Oliveira ECF, Baeta T, Brant APC, Silva-Filho A, Rocha ALL. Use of naproxen versus intracervical block for pain control during the 52-mg levonorgestrel-releasing intrauterine system insertion in young women: a multivariate analysis of a randomized controlled trial. BMC Womens Health. 2021 Oct 29;21(1):377. doi: 10.1186/s12905-021-01521-z. |
| 27032746 | Background | Black A, Guilbert E, Costescu D, Dunn S, Fisher W, Kives S, Mirosh M, Norman W, Pymar H, Reid R, Roy G, Varto H, Waddington A, Wagner MS, Whelan AM, Mansouri S. Canadian Contraception Consensus (Part 3 of 4): Chapter 7--Intrauterine Contraception. J Obstet Gynaecol Can. 2016 Feb;38(2):182-222. doi: 10.1016/j.jogc.2015.12.002. Epub 2016 Feb 26. English, French. |
| 39909325 | Background | Bayer LL, Ahuja S, Allen RH, Gold MA, Levine JP, Ngo LL, Mody S. Best practices for reducing pain associated with intrauterine device placement. Am J Obstet Gynecol. 2025 May;232(5):409-421. doi: 10.1016/j.ajog.2025.01.039. Epub 2025 Feb 3. |
| 28885425 | Background | Akers AY, Steinway C, Sonalkar S, Perriera LK, Schreiber C, Harding J, Garcia-Espana JF. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017 Oct;130(4):795-802. doi: 10.1097/AOG.0000000000002242. |
| 27823944 | Background | Abbas AM, Abdellah MS, Khalaf M, Bahloul M, Abdellah NH, Ali MK, Abdelmagied AM. Effect of cervical lidocaine-prilocaine cream on pain perception during copper T380A intrauterine device insertion among parous women: A randomized double-blind controlled trial. Contraception. 2017 Mar;95(3):251-256. doi: 10.1016/j.contraception.2016.10.011. Epub 2016 Nov 4. |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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