Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2017-02-22
2018-12-21
Brief Summary
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Detailed Description
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The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Non-Ketamine
This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.
Narcotics
The narcotic group will receive no ketamine but rather a more standard anesthetic
pain scale
0-10 pain scale. 0 = no pain and 10 = worst pain
Ketamine
This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.
Ketamine
Anesthesia of only Ketamine
pain scale
0-10 pain scale. 0 = no pain and 10 = worst pain
Interventions
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Ketamine
Anesthesia of only Ketamine
Narcotics
The narcotic group will receive no ketamine but rather a more standard anesthetic
pain scale
0-10 pain scale. 0 = no pain and 10 = worst pain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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David M Smyth, MSN
Role: PRINCIPAL_INVESTIGATOR
Shands Hospital at the University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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IRB201500836 -A
Identifier Type: -
Identifier Source: org_study_id
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