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Intravenous Acetaminophen for Craniotomy Patients (IVAC)

This study is currently recruiting participants.
Verified September 2016 by Swedish Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474304
First Posted: November 18, 2011
Last Update Posted: September 29, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Swedish Medical Center
November 9, 2011
November 18, 2011
September 29, 2016
November 2011
June 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01474304 on ClinicalTrials.gov Archive Site
  • Incidence of nausea during postoperative recovery [ Time Frame: 12 hours ]
  • Incidence of vomiting during postoperative recovery [ Time Frame: 12 hours ]
  • Severity of nausea during postoperative recovery [ Time Frame: 12 hours ]
  • Severity of vomiting during postoperative recovery [ Time Frame: 12 hours ]
Same as current
Not Provided
Not Provided
 
Intravenous Acetaminophen for Craniotomy Patients
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Craniotomy
Drug: Acetaminophen
1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery
  • 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.
    Intervention: Drug: Acetaminophen
  • No Intervention: No acetaminophen
    Patients will receive standard of care with no intraoperative doses of acetaminophen.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Becky Wood 206-320-7115 becky.wood@swedish.org
Contact: Nathan Hansen 206-320-3542 nathan.hansen@swedish.org
United States
 
 
NCT01474304
IVAC
20111619 ( Other Identifier: Western Institutional Review Board (WIRB) )
No
Not Provided
Not Provided
Swedish Medical Center
Swedish Medical Center
Mallinckrodt
Principal Investigator: Arthur Lam, MD, FRCPC Swedish Medical Center
Swedish Medical Center
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP