A Phase 4 interventional study of Prilocaine, Lidocaine and Lidocaine HCl 1% in Pain During Intrauterine Device Insertion, sponsored by Monakshi Sawhney. Not yet recruiting at 1 site in Canada. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Monakshi Sawhney · Phase 4, Interventional, and Treatment
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.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's planned enrollment of 66 is close to the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →This is the only study on the registry with Monakshi Sawhney as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will received prilocaine lidocaine injection, acetaminophen and naproxen
Drug: Lidocaine HCl 1%
Participants will receive lidocaine injection, acetaminophen and naproxen
Drug: Prilocaine, Lidocaine
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
Participants will receive 1% lidocaine injected into the cervix (10mls) 5 minutes prior to the procedure
Also known as: Lidocaine
Numerical Rating Scale
Zero is equivalent to no pain and 10 indicates the worst possible pain
Time frame: Baseline to end of treatment on day 1
State Trait Anxiety Inventory
Participants will answer a questionnaire on their level of anxiety.
Time frame: Baseline
McGill Pain Questionnaire
Participants will describe the pain/ if any they experienced during the procedure
Time frame: 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.
Time frame: 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
Time frame: end of treatment on day 1
Adverse Reactions
Participants will answer a questionnaire about any adverse reactions they may have experienced.
Time frame: at day 2
Demographic Information
Participants will answer a questionnaire about their current and past health. In addition, to sociodemographic information ( such as age, sex, gender)
Time frame: baseline
Plan to share: No — No individual participant data will be shared with other researchers
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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