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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00465439 |
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Date of registration:
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23/04/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal
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Scientific title:
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Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal. |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00465439 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Allison Cook, BScN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hamilton Health Science |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Percutaneous Coronary Intervention
- Femoral arterial sheath
Exclusion Criteria:
- Less than 18 years old
- Emergency procedure
- Transferred out of heart investigation unit prior to sheath removal
- Radial or brachial sheath
- Closure devise
- Venous sheath insitu
- Intra-aortic balloon pump insitu
- Tranvenous pacing
- Mechanical ventilation
- Cognitive impairment
- Unable to read English
- Lidocaine allergy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Syncope, Vasovagal
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Pain Intensity
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Intervention(s)
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Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine
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Primary Outcome(s)
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Incidence of vasovagal reaction during femoral sheath removal
[Time Frame: During sheath removal]
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Pain intensity during femoral sheath removal
[Time Frame: During sheath removal]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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