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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 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-22

No results posted yet for this study

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

Interventions

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.

DRUG

Lidocaine HCl 1%

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

Sponsors & Collaborators

  • Queen's University, Kingston, Ontario

    collaborator OTHER

  • Monakshi Sawhney

    lead OTHER

Principal Investigators

  • Monakshi Sawhney, NP, PhD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-14
Primary Completion
2027-04-14
Completion
2027-04-14

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546370 on ClinicalTrials.gov