- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01474304
Intravenous Acetaminophen for Craniotomy Patients (IVAC)
September 27, 2016 updated by: Swedish Medical Center
Intravenous Acetaminophen for Craniotomy Patients: A Single-blinded, Randomized Controlled Trial to Evaluate the Effect of Intravenous Acetaminophen Administered at Induction and Emergence From Craniotomy
Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy.
Opioids exacerbate symptoms of nausea and vomiting.
Reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Becky Wood
- Phone Number: 206-320-7115
- Email: becky.wood@swedish.org
Study Contact Backup
- Name: Nathan Hansen
- Phone Number: 206-320-3542
- Email: nathan.hansen@swedish.org
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98122
- Recruiting
- Swedish Medical Center Cherry Hill Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years of age
- 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:
- Significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery
|
No Intervention: No acetaminophen
Patients will receive standard of care with no intraoperative doses of acetaminophen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total narcotic dose administered over the first 12 hours of postoperative recovery.
Time Frame: 12 hours
|
Intensive care nurses will ask subject about pain and nausea every 15 minutes for the first two hours immediately after surgery and then every hour afterward for up to 12 hours.
Nurses will record subject response and opioid doses given.
|
12 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of nausea during postoperative recovery
Time Frame: 12 hours
|
12 hours
|
Incidence of vomiting during postoperative recovery
Time Frame: 12 hours
|
12 hours
|
Severity of nausea during postoperative recovery
Time Frame: 12 hours
|
12 hours
|
Severity of vomiting during postoperative recovery
Time Frame: 12 hours
|
12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Arthur Lam, MD, FRCPC, Swedish Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
November 9, 2011
First Submitted That Met QC Criteria
November 15, 2011
First Posted (Estimate)
November 18, 2011
Study Record Updates
Last Update Posted (Estimate)
September 29, 2016
Last Update Submitted That Met QC Criteria
September 27, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IVAC
- 20111619 (Other Identifier: Western Institutional Review Board (WIRB))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Craniotomy
-
RevBioNot yet recruitingCraniotomyUnited States
-
NEOS SurgeryCompleted
-
Yonsei UniversityCompletedCraniotomyKorea, Republic of
-
University of LiegeUnknown
-
National Taiwan University HospitalRecruiting
-
Children's Hospital of PhiladelphiaChildren's Anesthesiology Associates, Ltd.Completed
-
George Papanicolaou HospitalUnknown
-
Synthes GmbHWithdrawnCraniotomy | Craniectomy | E04.525.190Spain, Switzerland, Finland, Germany, Colombia, Singapore, United Kingdom, Austria, Belgium, Chile, Costa Rica, Czech Republic, Denmark, France, Portugal
-
Azienda Ospedaliera San Gerardo di MonzaCompletedAnesthesia | Craniotomy | NeurosurgeryItaly
-
University of ThessalyRecruiting
Clinical Trials on Acetaminophen
-
Massachusetts General HospitalCompletedPain, Postoperative | Infertility, FemaleUnited States
-
Kaveh Aslani, MDCompletedAirway Obstruction | Tonsillitis | Difficulty SwallowingUnited States
-
Taipei Medical University WanFang HospitalUnknownCervical Radiculopathy | Radicular Pain | Acute Neck Pain | Cervicobrachial PainTaiwan
-
Medical University of South CarolinaCompletedPain, PostoperativeUnited States
-
MallinckrodtTerminatedAcute Pain, PostoperativeUnited States
-
Duke UniversityCompletedOsteoarthritis | Acetaminophen | Arthroplasty, Hip ReplacementUnited States
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruiting
-
Spectrum Health HospitalsTerminatedHip FractureUnited States
-
Babiash, Kimberly H., M.D.Unknown
-
Beth Israel Deaconess Medical CenterNational Center for Research Resources (NCRR); Harvard UniversityCompletedAcetaminophen Poisoning | Acetaminophen Metabolism | Drug Metabolism by ExcipientsUnited States