Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery
NCT ID: NCT03261310
Last Updated: 2017-08-25
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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UNKNOWN
NA
55 participants
INTERVENTIONAL
2013-05-31
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acetaminophen & Craniotomy
Drug: Acetaminophen 1000mg administered intravenously during craniotomy
Acetaminophen or Placebo
Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
Placebo & Craniotomy
Placebo administered intravenously during craniotomy.
Acetaminophen or Placebo
Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
Acetaminophen & Laminectomy
Acetaminophen 1000mg administered intravenously during laminectomy.
Acetaminophen or Placebo
Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
Placebo & Laminectomy
Placebo administered during laminectomy.
Acetaminophen or Placebo
Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
Interventions
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Acetaminophen or Placebo
Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
Eligibility Criteria
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Inclusion Criteria
* undergoing non-emergent craniotomy or single level lumbar laminectomy
* must be able to rate pain on a 0-10 scale post-operatively
Exclusion Criteria
* allergy to acetaminophen
* age less than 18 years
* renal failure with creatinine clearance less than 30
* pregnancy
* altered mentation with inability to report pain score
* patients who have received acetaminophen within 6 hours of surgery
* patients in which a neuraxial technique has been performed for surgery
* prisoners
18 Years
90 Years
ALL
Yes
Sponsors
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Brooke Army Medical Center
FED
Responsible Party
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Dimitar Dentchev
Staff Anesthesiologist
Principal Investigators
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Dimitar Dentchev, MD
Role: PRINCIPAL_INVESTIGATOR
BAMC
Betsy Murray, MD
Role: STUDY_CHAIR
BAMC
Robert Vietor, MD
Role: STUDY_CHAIR
BAMC
Jonathan Deeth, MD
Role: STUDY_CHAIR
BAMC
Daniel Stypula, DO
Role: STUDY_CHAIR
BAMC
Locations
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Brooke Army Medical Center
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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386486-1
Identifier Type: -
Identifier Source: org_study_id
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