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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01445756 |
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Date of registration:
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23/08/2011 |
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Primary sponsor: |
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Public title:
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Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion
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Scientific title:
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Topical Lidocaine for Pain Control With IUD Insertion: A Randomized Controlled Trial |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01445756 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
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Countries of recruitment
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United States
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Contacts
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Name:
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Mary Landry, MD |
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Address:
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Telephone:
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608-265-5615 |
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Email:
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mslandry@uhs.wisc.edu |
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Affiliation:
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Name:
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Mary Landry, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Wisconsin Health Services |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must be at least 18 years old
Exclusion Criteria:
- Age <18
- Non-English speaking
- Illiterate
- History of pregnancy with delivery >20 weeks
- History of prior IUD insertion or attempt
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Drug: Lidocaine
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Drug: Placebo
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Primary Outcome(s)
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Change in pain level from no Lidocaine administered to after Lidocaine is administered
[Time Frame: Pain assessments prior to procedure, immediately after procedure, and 10 minutes after the procedure]
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Secondary ID(s)
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H-2010-0062
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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