Lorazepam for Pain During IUD Insertion

Overseen By Viktoriya Ovsepyan, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Opioids, Benzodiazepines

Disqualifiers: Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 appointment visit

25 Participants Needed

Trial Summary

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 lorazepam generally safe for use in humans?

Lorazepam is generally considered safe for use in humans, with studies showing minimal irritative effects on veins and a high rate of patient acceptance. The most common side effect reported is drowsiness, especially if not administered well before surgery. ^{1 2 3 4 5}

How does the drug Lorazepam differ from other drugs for pain during IUD insertion?

Lorazepam is unique because it is primarily used as an anti-anxiety medication, which may help reduce anxiety-related pain perception during IUD insertion, unlike other treatments that focus directly on pain relief. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Jensena Carlson, MD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Lorazepam administration prior to IUD insertion procedure Experimental Treatment 2 Interventions

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

Approved in United States as Ativan for:

• Anxiety disorders
• Short-term relief of anxiety symptoms
• Preoperative sedation

Approved in European Union as Ativan for:

• Anxiety disorders
• Insomnia
• Preoperative sedation

Approved in Canada as Ativan for:

• Anxiety disorders
• Short-term relief of anxiety symptoms
• Preoperative sedation

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of injectable lorazepam in status epilepticus: a comparative study in French-speaking hospitals]. Curatolo, N., Prot-Labarthe, S., Auvin, S., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. Crawford, M., Davy, S., Book, N., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Pain and clinical thrombophlebitis following intravenous diazepam and lorazepam. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A premarketing multicenter trial of lorazepam injection. [2013]

3. France pubmed.ncbi.nlm.nih.gov

[Use of injectable lorazepam in status epilepticus: a comparative study in French-speaking hospitals]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Suppressive effects of intrathecal application of diazepam on visceral pain and hyperalgesia induced by intracolonic instillation of formalin. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Lidocaine reduces intravenous diazepam pain. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Intrauterine infusion of lidocaine does not reduce pain scores during IUD insertion. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Effect of intracervical anesthesia on pain associated with the insertion of the levonorgestrel-releasing intrauterine system in women without previous vaginal delivery: a RCT. [2022]