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Intravenous Acetaminophen for Craniotomy Patients (IVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01474304
Recruitment Status : Unknown
Verified September 2016 by Swedish Medical Center.
Recruitment status was:  Recruiting
First Posted : November 18, 2011
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):
Swedish Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Craniotomy Drug: Acetaminophen Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : November 2011
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine

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.
Drug: Acetaminophen
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Incidence of nausea during postoperative recovery [ Time Frame: 12 hours ]
  2. Incidence of vomiting during postoperative recovery [ Time Frame: 12 hours ]
  3. Severity of nausea during postoperative recovery [ Time Frame: 12 hours ]
  4. Severity of vomiting during postoperative recovery [ Time Frame: 12 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01474304

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Contact: Becky Wood 206-320-7115
Contact: Nathan Hansen 206-320-3542

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United States, Washington
Swedish Medical Center Cherry Hill Campus Recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Swedish Medical Center
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Principal Investigator: Arthur Lam, MD, FRCPC Swedish Medical Center

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Responsible Party: Swedish Medical Center Identifier: NCT01474304     History of Changes
Other Study ID Numbers: IVAC
20111619 ( Other Identifier: Western Institutional Review Board (WIRB) )
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Keywords provided by Swedish Medical Center:
tumor resection
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs