Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing IUD
NCT ID: NCT02799641
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2016-07-31
2022-06-30
Brief Summary
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Detailed Description
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In order to eliminate barriers to selecting the IUD for contraception, improve the experience of women undergoing placement, and standardize local practices, investigators want to investigate analgesic options affecting patients' perception of pain during the various steps of IUD insertion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
Control arm receives ibuprofen, placebo pill, and placebo injection.
Placebo pill
Placebo pill
Placebo injection
Placebo injection
Treatment
Treatment arm receives ibuprofen, diazepam pill, and lidocaine injection.
Diazepam
5 mg Diazepam
Lidocaine
2 ml of 2% lidocaine
Interventions
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Diazepam
5 mg Diazepam
Lidocaine
2 ml of 2% lidocaine
Placebo pill
Placebo pill
Placebo injection
Placebo injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Desires to undergo placement of a levonorgestrel containing intrauterine device
Exclusion Criteria
* Patients with a history of drug abuse.
* History of a prior IUD
* Current use of medications for anxiety
* Also, a diagnosis of chronic pain.
18 Years
FEMALE
Yes
Sponsors
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TriHealth Inc.
OTHER
Responsible Party
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Principal Investigators
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Catrina Crisp, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
TriHealth Inc.
Locations
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Bethesda North Hospital
Cincinnati, Ohio, United States
Countries
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References
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Scavuzzi A, Souza AS, Costa AA, Amorim MM. Misoprostol prior to inserting an intrauterine device in nulligravidas: a randomized clinical trial. Hum Reprod. 2013 Aug;28(8):2118-25. doi: 10.1093/humrep/det240. Epub 2013 Jun 5.
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Other Identifiers
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15-062
Identifier Type: -
Identifier Source: org_study_id
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