Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study

The objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. The target population for this study will be 25 adult participants scheduled for an IUD insertion at a UW Family Medicine residency clinic. Participants will be followed for 1 appointment visit.

Study Overview

• Status: Withdrawn
• Conditions: Pain; IUD
• Intervention / Treatment: Drug: Lorazepam 1 mg; Drug: Ibuprofen 800 mg

Detailed Description

The purpose of the research is to evaluate the feasibility of prescribing lorazepam and measuring its effect on anxiety and pain with IUD insertion. The descriptive data from this study will be used to offer guidance for how to implement a larger scale study in the future.

Primary endpoint: Assess preliminary differences in pain and anxiety scores pre-IUD insertion and post-IUD insertion using a Mann-Whitney U test. Participants will score their anxiety and pain levels pre-procedure and post-procedure using a 10cm visual analogue scale. This will be a one arm trial where all subjects will receive 1mg lorazepam and 800mg ibuprofen prior to the procedure.

Secondary endpoints

• Discuss if there was a difference in pain and anxiety scores among nulliparous (no previous childbirths) and multiparous (one or more previous childbirths) participants.
• Summarize recruitment rates, adherence to lorazepam prescription, completion rates of questionnaires and scales
• Discuss participant's experiences with taking lorazepam and participating in the study
• Assess investigator's experience with the trial via a focus group

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • UW Family Medicine Residency Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants who undergo IUD insertion and complete the visual analogue scales to rate their anxiety and pain level prior to the procedure and after the procedure.
• Participants must have a driver take them to their appointment if they take lorazepam prior to their arrival at the clinic.
• Participants must have a driver take them home after the procedure as well.
• Participants must consent to email communication since they will sign the consent forms electronically

Exclusion Criteria:

• Participants who do not show up for their appointment.
• Participants who receive cervical blocks or other analgesic method during IUD insertion.
• Participants who have a history of substance use disorder.
• Participants who are taking medications with a central nervous system (CNS) depressant effect (ex: opioids, benzodiazepines).
• Participants who are not able to sign an electronic consent form.
• Participants who do not have a driver to take them to their appointment and to take them home after the procedure.
• Participants who do not agree to sign consent forms electronically.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lorazepam administration prior to IUD insertion procedure	Drug: Lorazepam 1 mg; 1 mg oral lorazepam, a sedative used to relieve anxiety; Drug: Ibuprofen 800 mg; 800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for Pain	Participant will be asked to rate their pain on a scale of 0 (no pain) to 10 (severe pain).	before and after the procedure (up to 1 hour)
Visual Analogue Scale for Anxiety	Participant will be asked to rate their anxiety on a scale of 0 (no anxiety) to 10 (severe anxiety).	before and after the procedure (up to 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Pain Scores for Nulliparous and Multiparous Participants	Comparison of mean pain scores between participants that have never had childbirth to those who have.	before and after the procedure (up to 1 hour)
Mean Anxiety Scores for Nulliparous and Multiparous Participants	Comparison of mean anxiety scores between participants that have never had childbirth to those who have.	before and after the procedure (up to 1 hour)
Number of Participants Recruited	Feasibility will in part be measured with recruitment rates.	up to 2 months (estimated time period of recruitment)
Number of Participants with lorazepam prescription adherence	Feasibility will in part be measured with adherence rates.	up to 2 months (estimated time period of recruitment)
Number of Participants Who Completed All Surveys	Feasibility will in part be measured with survey completion rates.	up to 2 months (estimated time period of recruitment)
Qualitative Measure: Participant Experience	Participants will be asked questions about their experience taking lorazepam and to provide feedback about the study. Participant answers will be coded and themed to report as participant counts.	post-procedure (up to 1 hour)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Jensena Carlson, MD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: IUD insertion
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Benzazepines; Acids, Carbocyclic; Benzodiazepines; Phenylpropionates; Benzodiazepinones; Ibuprofen; Lorazepam
• Other Study ID Numbers: 2024-0655; A532014 (Other Identifier: UW Madison); Protocol Version 6/5/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes