Intravenous Acetaminophen for Craniotomy Patients (IVAC)

This study is currently recruiting participants.
Verified May 2013 by Swedish Medical Center
Sponsor:
Collaborator:
Cadence Pharmaceuticals
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01474304
First received: November 9, 2011
Last updated: May 29, 2013
Last verified: May 2013

November 9, 2011
May 29, 2013
November 2011
December 2013   (final data collection date for primary outcome measure)
Total narcotic dose administered over the first 12 hours of postoperative recovery. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Incidence of vomiting during postoperative recovery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Severity of nausea during postoperative recovery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Severity of vomiting during postoperative recovery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
December 2013   (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
Both
18 Years and older
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
No
Swedish Medical Center
Swedish Medical Center
Cadence Pharmaceuticals
Principal Investigator: Arthur Lam, MD, FRCPC Swedish Medical Center
Swedish Medical Center
May 2013

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