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Lorazepam for Pain During IUD Insertion

VO
Overseen ByViktoriya Ovsepyan, MD
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lorazepam, a medication often used to ease anxiety, can reduce anxiety and pain during the insertion of an Intrauterine Device (IUD). The researchers aim to determine if lorazepam is helpful and practical for individuals receiving an IUD. Suitable participants are those planning to get an IUD at a specific clinic and who can arrange for transportation to and from the appointment. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take medications with a central nervous system depressant effect, like opioids or benzodiazepines, to participate.

Is there any evidence suggesting that lorazepam is likely to be safe for humans?

Research has shown that lorazepam is generally safe for people. Studies indicate it causes minimal vein irritation and patients usually tolerate it well. The FDA has already approved lorazepam for other uses, supporting its safety profile.

Although specific data on side effects during IUD insertion is lacking, lorazepam is known for its calming effects, which may help reduce anxiety and pain during the procedure. As this is a Phase 2 trial, safety remains under close observation, but past use of lorazepam suggests it is well-tolerated.12345

Why do researchers think this study treatment might be promising?

Lorazepam is unique because it offers a novel approach to managing pain during IUD insertion by targeting anxiety and muscle tension, which can exacerbate discomfort. Unlike the standard of care, which often relies on local anesthetics or nonsteroidal anti-inflammatory drugs, lorazepam is a benzodiazepine that helps calm the nervous system, potentially making the procedure more tolerable. Researchers are excited about this treatment because it could improve the overall experience for patients, offering a more comprehensive pain management option that addresses both physical and psychological aspects of discomfort.

What evidence suggests that lorazepam might be an effective treatment for pain during IUD insertion?

Research has shown that lorazepam might help with anxiety and pain during IUD insertion. Although few studies focus specifically on lorazepam for this use, its calming effects can reduce anxiety. Lowering anxiety might also lessen the perception of pain. Many healthcare providers use medications to manage pain during IUD procedures, often achieving good results. In this trial, participants will receive lorazepam before the IUD insertion to evaluate its effectiveness. Given its known benefits in reducing anxiety and its common use in similar situations, lorazepam could prove effective.13467

Who Is on the Research Team?

JC

Jensena Carlson, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for adults who are scheduled to have an IUD inserted at a UW Family Medicine residency clinic. They must be able to rate their anxiety and pain, agree to have a driver for clinic visits, and consent to email communication.

Inclusion Criteria

I agree to communicate via email for signing consent forms.
I have arranged for someone to drive me home after the procedure.
I will rate my anxiety and pain before and after my IUD insertion.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lorazepam and ibuprofen prior to IUD insertion to measure effects on anxiety and pain

1 appointment visit
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 1 hour post-procedure

What Are the Treatments Tested in This Trial?

Interventions

  • Lorazepam
Trial Overview The study is testing if taking Lorazepam (1 mg) before getting an IUD can help with anxiety and pain during the procedure. Participants will also take Ibuprofen (800 mg), and they'll be observed for one appointment visit.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Lorazepam administration prior to IUD insertion procedureExperimental Treatment2 Interventions

Lorazepam is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Ativan for:
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Approved in European Union as Ativan for:
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Approved in Canada as Ativan for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Published Research Related to This Trial

In a double-blinded randomized controlled trial with 72 participants, oral ketorolac (20 mg) significantly reduced pain during IUD placement compared to a placebo, with pain ratings of 4.2 versus 5.7 at deployment.
Ketorolac also decreased overall pain ratings (3.6 vs. 4.9) and pain 10 minutes after the procedure (1.1 vs. 2.5), demonstrating its efficacy in managing pain associated with IUD insertion.
Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial.Crawford, M., Davy, S., Book, N., et al.[2018]
In a survey of 12 hospitals within the Mother-Child French-speaking Network, it was found that injectable lorazepam (IL) is only used in one hospital in France, while it is widely marketed and used in Switzerland, Canada, and Belgium for pediatric status epilepticus.
Although pharmacokinetic data suggest that IL may be preferable to injectable diazepam, there is currently no evidence proving that IL is superior in treating pediatric status epilepticus, highlighting inconsistencies in treatment protocols across different countries.
[Use of injectable lorazepam in status epilepticus: a comparative study in French-speaking hospitals].Curatolo, N., Prot-Labarthe, S., Auvin, S., et al.[2015]

Citations

Prescribing Lorazepam for IUD Insertion: Pilot Feasibility ...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 ...
Lorazepam for Pain During IUD InsertionIn a double-blinded randomized controlled trial with 72 participants, oral ketorolac (20 mg) significantly reduced pain during IUD placement compared to a ...
Provider Perspectives on Analgesic Use in Intrauterine ...The majority of respondents reported offering some sort of analgesic for IUD insertion procedures, with nonsteroidal anti-inflammatory drugs being the most ...
Prescribing Lorazepam for IUD Insertion: Pilot Feasibility ...A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
An Overview of Pharmacologic and Non- ...The following describes different pharmacologic and non-pharmacologic options clinicians can offer patients to manage pain and discomfort during IUD insertion.
Clinical outcomes of intrauterine device insertions by newly ...Among 2582 IUD acceptors who underwent first attempted IUD insertion, 141 experienced insertion failure (5.46%) and seven had uterine perforation (0.27%).
loreev xr - accessdata.fda.govThe safety of LOREEV XR in adults is based on studies with lorazepam tablets. The following adverse reactions associated with the use of lorazepam tablets ...
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