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

NCT07546370 | Not Yet Recruiting Phase 4

• 1 other identifier: The PLAN IUD Trial
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain During Intrauterine Device Insertion

Keywords

pain; intrauterine device; prilocaine-lidocaine; lidocaine; contraception

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale

  Zero is equivalent to no pain and 10 indicates the worst possible pain

  Baseline to end of treatment on day 1

Secondary Outcomes (5)

• State Trait Anxiety Inventory

  Baseline

• McGill Pain Questionnaire

  end of treatment on day 1

• Ease of Insertion

  end of treatment on day 1

• Non Pharmacological Measures

  end of treatment on day 1

• Adverse Reactions

  at day 2

Other Outcomes (1)

• Demographic Information

  baseline

Study Arms (2)

Prilocaine Lidocaine Arm

ACTIVE COMPARATOR

Participants will received prilocaine lidocaine injection, acetaminophen and naproxen

Drug: Lidocaine HCl 1%

Lidocaine injection

ACTIVE COMPARATOR

Participants will receive lidocaine injection, acetaminophen and naproxen

Drug: Prilocaine, Lidocaine

Interventions

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.

Also known as: EMLA

Lidocaine injection

Lidocaine HCl 1% DRUG

Participants will receive 1% lidocaine injected into the cervix (10mls) 5 minutes prior to the procedure

Also known as: Lidocaine

Prilocaine Lidocaine Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monakshi Sawhney: lead
• Queen's University, Kingston, Ontario: collaborator

Study Sites (1)

Woodlawn Medical Clinic

Dartmouth, Nova Scotia, B2W 2S7, Canada

Location

Related Publications (14)

• Werger, M., Kirubarajan, A., Gryn, A., Ivanisevic, S., Salim, S., Wang, S., Huszti, E., Flamer, D., Spitzer, R., Jacobson, M., & Sobel, M. (2025). A double-blind, triple-arm randomized controlled trial of 1% lidocaine paracervical block for intrauterine device (IUD) insertion. Journal of Obstetrics and Gynaecology Canada, 47(6), Article 102901. https://doi.org/10.1016/j.jogc.2025.102901

  BACKGROUND

• Tavakolian, S., Doulabi, M. A., Baghban, A. A., Mortazavi, A., & Ghorbani, M. (2015). Lidocaine-prilocaine cream as analgesia for IUD insertion: A prospective, randomized, controlled, triple blinded study. Global Journal of Health Science, 7(4), 399-404. https://doi.org/10.5539/gjhs.v7n4p399

  BACKGROUND

• Samy, A., Abbas, A. M., Mahmoud, M., Taher, A., Awad, M. H., El husseiny, T., Hussein, M., Ramadan, M., Shalaby, M. A., El sharkawy, M., Hatem, D., Alaa-El-din Wali, A., Abd-el-fatah, S. M., Hussein, A. H., & Haggag, H (2019). Evaluating different pain lowering medications during intrauterine device insertion: A systematic review and network meta-analysis. Fertility and Sterility, 111(3), 553-61. e4. https://doi.org/10.1016/j.fertnstert.2018.11.012

  BACKGROUND

• Nguyen, L., Lamarche, L., Lennox, R., Ramdyal, A., Patel, T., Black, M., & Mangin, D. (2020). Strategies to mitigate anxiety and pain in intrauterine device insertion: A systematic review. Journal of Obstetrics and Gynecology Canada. 42(9), 1138-1146.

  BACKGROUND

• Karasu, Y., Comert, D.K., Karadag, B., & Ergun, Y. (2017). Lidocaine for pain control during intrauterine device insertion. The Journal of Obstetrics and Gynaecology Research, 43(6), 1061-1066. https://doi.org/10.1111/jog.13308

  BACKGROUND

• Mody, S. K., Farala, J. P., Jimenez, B., Nishikawa, M., & Ngo, L. L. (2018). Paracervical block for intrauterine device placement among nulliparous women: A randomized controlled trial. Obstetrics and Gynecology, 132(3), 575-582. https://doi.org/10.1097/AOG.0000000000002790

  BACKGROUND

• Lopes-Garcia, E. A., Carmona, E. V., Monteiro, I., & Bahamondes, L. (2023). Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery. The European Journal of Contraception & Reproductive Health Care, 28(3), 163-167. https://doi.org/10.1080/13625187.2023.2189500

  BACKGROUND

• Hunter, T. A., Sonalkar, S., Schreiber, C. A., Perriera, L. K., Sammel, M. D., & Akers, A. Y. (2020). Anticipated Pain During Intrauterine Device Insertion. Journal of Pediatric & Adolescent Gynecology, 33(1), 27-32. https://doi.org/10.1016/j.jpag.2019.09.007

  BACKGROUND

• Hawker, G. A., Mian, S., Kendzerska, T., & French, M. (2011). 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 & Research, 63(S11), S240-S252. https://doi.org/10.1002/acr.20543

  BACKGROUND

• de Oliveira, E. C. F., Baêta, T., Brant, A. P. C., Silva-Filho, A., & Rocha, A. L. L. (2021). 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 Women's Health, 21(1), Article 377. https://doi.org/10.1186/s12905-021-01521-z

  BACKGROUND

• Black, A., Guilbert, A., Costescu, D., Dunn, S., Fisher, W., Kives, S., Mirosh, M., Norman, W., Pymar, H., Reid, R., Roy, G., Varto, H., Waddington, A., Wagner, M.S., & Whelan, A.M. (2016). Canadian contraception consensus (part 3 of 4): Chapter 7- Intrauterine contraception. Journal of Obstetrics and Gynecology Canada, 38(2), 182-222. https://doi.org/10.1016/j.jogc.2015.12.002

  BACKGROUND

• Bayer, L. L., Ahuja, S., Allen, R. H., Levine, J., Ngo, L. L., & Mody, S. (2025). Best practices for reducing pain associated with intrauterine device placement. American Journal of Obstetrics & Gynecology, 232(5), 409-421. Doi:10.1016/j.ajog.2025.01.039.

  BACKGROUND

• Akers, A. Y., Steinway, C., Sonalkar, S., Perriera, L. K., Schreiber, C., Harding, J., & Garcia-Espana, J. F. (2017). Reducing pain during intrauterine device insertion: A randomized controlled trial in adolescents and young women. Obstetrics & Gynecology, 130(4), 795-802. https://doi.org/10.1097/AOG.0000000000002242

  BACKGROUND

• Abbas, A. M., Abdellah, M. S., Khalaf, M., Bahloul, M., Abdellah, N. H., Ali, M. K., & Abdelmagied, A. M. (2017). 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, 95(3), 251-256. https://doi.org/10.1016/j.contraception.2016.10.011

  BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Monakshi Sawhney, NP, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aprill D Susin, NP, PhD(c)

CONTACT

19029890116; aprill.susin@queensu.ca

Monakshi Sawhney, NP, PhD

CONTACT

14168160487; mona.sawhney@queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of School of Nursing and Department of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 22, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): April 14, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)