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
PHASE2
80 participants
INTERVENTIONAL
2011-11-30
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
SUPPORTIVE_CARE
SINGLE
Study Groups
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Acetaminophen
Craniotomy patients will receive a 1000 mg dose of intravenous (IV) acetaminophen before incision and a second 1000 mg dose of IV acetaminophen 6 hours later.
Acetaminophen
1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery
No acetaminophen
Patients will receive standard of care with no intraoperative doses of acetaminophen.
No interventions assigned to this group
Interventions
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Acetaminophen
1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery
Eligibility Criteria
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Inclusion Criteria
* Weigh at least 50 kg (110.23 lbs)
* Undergoing open, elective intracranial procedure for
* tumor resection
* aneurysm clipping
* revascularization
* Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4
* Able to provide written informed consent
Exclusion Criteria
* Unable to communicate symptoms
* Current daily opioid use (\>40 mg morphine equivalent)
* Tramadol use
* Treated with MAO (monoamine oxidase inhibitors) inhibitors within 10 days of surgery
* Treated with any amount of acetaminophen within 8 hours of anesthesia for surgery
* Allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines
* Pregnancy
* Impaired liver function
* Participation in interventional clinical study within the last 30 days
* Known or suspected history of alcohol or drug abuse
* Surgery for resection of acoustic neuroma
* Transphenoidal tumor resection
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Swedish Medical Center
OTHER
Responsible Party
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Principal Investigators
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Arthur Lam, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Swedish Medical Center
Locations
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Swedish Medical Center Cherry Hill Campus
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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20111619
Identifier Type: OTHER
Identifier Source: secondary_id
IVAC
Identifier Type: -
Identifier Source: org_study_id
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