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Benzodiazepine
Lorazepam for Pain During IUD Insertion
Phase 2
Waitlist Available
Led By Jensena Carlson, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months (estimated time period of recruitment)
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if giving patients lorazepam before getting an IUD inserted can help reduce anxiety and pain during the procedure. They will study 25 adult patients at a family medicine clinic and
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Lorazepam may cause drowsiness, dizziness, tiredness, blurred vision, or unsteadiness. Ibuprofen can lead to stomach upset, nausea, vomiting, headache, diarrhea, constipation or dizziness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 months (estimated time period of recruitment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months (estimated time period of recruitment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Analogue Scale for Anxiety
Visual Analogue Scale for Pain
Secondary study objectives
Mean Anxiety Scores for Nulliparous and Multiparous Participants
Mean Pain Scores for Nulliparous and Multiparous Participants
Number of Participants Recruited
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lorazepam administration prior to IUD insertion procedureExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorazepam 1 mg
2015
Completed Phase 1
~290
Ibuprofen 800 mg
2007
Completed Phase 4
~1030
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,237 Previous Clinical Trials
3,200,974 Total Patients Enrolled
17 Trials studying Pain
10,204 Patients Enrolled for Pain
Jensena Carlson, MDPrincipal InvestigatorUW School of Medicine and Public Health