Pain During Intrauterine Device InsertionPhase 4NCT07546370
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
A Phase 4 study testing Prilocaine, Lidocaine and Lidocaine HCl 1% in people with Pain During Intrauterine Device Insertion, run by Monakshi Sawhney at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain During Intrauterine Device Insertion
- What is being tested?
- Prilocaine, Lidocaine and Lidocaine HCl 1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2026to 14 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Woodlawn Medical Clinic
Dartmouth, Nova Scotia, B2W 2S7
Aprill Susin, NP, 19029890116, aprillnegus@gmail.com
About this study
Official title: The PLAN IUD Trial: 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: A Randomized Controlled Trial
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:
Read more
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.
Read the 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.
- Being tested
- Prilocaine, Lidocaine, Lidocaine HCl 1%
- Keywords
- pain, intrauterine device, prilocaine-lidocaine, lidocaine, contraception
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prilocaine, LidocaineDrug
Also called EMLA
Participants in this arm will receive prilocaine lidocaine cream to their cervix (4 grams) to their cervix 5 minutes prior to the procedure.
Lidocaine HCl 1%Drug
Also called Lidocaine
Participants will receive 1% lidocaine injected into the cervix (10mls) 5 minutes prior to the procedure
| Study group | Role | What they receive |
|---|---|---|
| Prilocaine Lidocaine Arm | Active comparator | Participants will received prilocaine lidocaine injection, acetaminophen and naproxen Receives: Drug: Lidocaine HCl 1% |
| Lidocaine injection | Active comparator | Participants will receive lidocaine injection, acetaminophen and naproxen Receives: Drug: Prilocaine, Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Zero is equivalent to no pain and 10 indicates the worst possible pain
Measured: Baseline to end of treatment on day 1
Secondary outcomes (5)
State Trait Anxiety Inventory
Participants will answer a questionnaire on their level of anxiety.
Measured: Baseline
McGill Pain Questionnaire
Participants will describe the pain/ if any they experienced during the procedure
Measured: 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.
Measured: 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
Measured: end of treatment on day 1
Adverse Reactions
Participants will answer a questionnaire about any adverse reactions they may have experienced.
Measured: at day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start14 Apr 2026 (estimated)
- Primary completion14 Apr 2027 (estimated)
- Study completion14 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pain During Intrauterine Device InsertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monakshi Sawhney
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario
- Responsible party
- Sponsor-investigator, Monakshi Sawhney, Queen's University
- Investigators
- Monakshi Sawhney, NP, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546370
- Sponsor's protocol ID
- The PLAN IUD Trial
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers
Publications
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.
PubMed 41587631Tavakolian 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.
PubMed 25946948Samy 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.
PubMed 30611553Nguyen 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.
PubMed 31882291Karasu 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.
PubMed 28503818Mody 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.
PubMed 30095776Lopes-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.
PubMed 36961099Hunter 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.
PubMed 31563628Hawker 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.
PubMed 22588748de 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.
PubMed 34715839Black 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.
PubMed 27032746Bayer 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.
PubMed 39909325Akers 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.
PubMed 28885425Abbas 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.
PubMed 27823944
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PLAN IUD Trial: 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: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07546370
- Acronym / sponsor ID
- The PLAN IUD Trial
- Keywords
- pain, intrauterine device, prilocaine-lidocaine, lidocaine, contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Monakshi SawhneyUniversity, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario
- Study start
- 14 Apr 2026 (estimated)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 14 Apr 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prilocaine Lidocaine Arm | Active comparator | Drug: Lidocaine HCl 1%Participants will received prilocaine lidocaine injection, acetaminophen and naproxen |
| Lidocaine injection | Active comparator | Drug: Prilocaine, LidocaineParticipants will receive lidocaine injection, acetaminophen and naproxen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prilocaine, LidocaineAlso: EMLAParticipants in this arm will receive prilocaine lidocaine cream to their cervix (4 grams) to their cervix 5 minutes prior to the procedure. | Drug | Lidocaine injection |
| Lidocaine HCl 1%Also: LidocaineParticipants will receive 1% lidocaine injected into the cervix (10mls) 5 minutes prior to the procedure | Drug | Prilocaine Lidocaine Arm |
Primary outcome
Numerical Rating Scale
Time frame: Baseline to end of treatment on day 1
Zero is equivalent to no pain and 10 indicates the worst possible pain
5 secondary outcomes
State Trait Anxiety Inventory
Time frame: Baseline
McGill Pain Questionnaire
Time frame: end of treatment on day 1
Ease of Insertion
Time frame: end of treatment on day 1
Non Pharmacological Measures
Time frame: end of treatment on day 1
Adverse Reactions
Time frame: at day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 41587631Kirubarajan 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.
- Background: PubMed 25946948Tavakolian 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.
- Background: PubMed 30611553Samy 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.
- Background: PubMed 31882291Nguyen 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.
- Background: PubMed 28503818Karasu 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.
- Background: PubMed 30095776Mody 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.
- Background: PubMed 36961099Lopes-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.
- Background: PubMed 31563628Hunter 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.
- Background: PubMed 22588748Hawker 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.
- Background: PubMed 34715839de 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.
- Background: PubMed 27032746Black 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.
- Background: PubMed 39909325Bayer 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers
Related trials for Pain During Intrauterine Device Insertion
Recruiting
Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial
Intrauterine Device Placement
Not yet recruiting
LI4 Acupuncture for Pain During Intrauterine Device Insertion
Pain Associated With Intrauterine Device Insertion
Recruiting
Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
Pain
Enrolling by invitation
Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)
Pain
Not yet recruiting
MUSIC Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.
Intrauterine Device
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monakshi Sawhney, NP, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prilocaine, Lidocaine and Lidocaine HCl 1% in people with Pain During Intrauterine Device Insertion, run by Monakshi Sawhney at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aprill D Susin, NP, PhD(c) (19029890116, aprill.susin@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: Baseline to end of treatment on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07546370, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.