Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study

University of Wisconsin (UW)

Status and phase

Begins enrollment this month

Phase 2

Conditions

Pain

IUD

Treatments

Drug: Lorazepam 1 mg

Drug: Ibuprofen 800 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT06496854

A532014 (Other Identifier)

Protocol Version 6/5/2024 (Other Identifier)

2024-0655

Details and patient eligibility

About

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.

Full 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

Enrollment

25 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.