Intravenous Acetaminophen for Craniotomy Patients (IVAC)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Craniotomy
Drug: Acetaminophen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474304

Contacts
Contact: Becky Wood 206-320-7115 becky.wood@swedish.org
Contact: Nathan Hansen 206-320-3542 nathan.hansen@swedish.org

Locations
United States, Washington
Swedish Medical Center Cherry Hill Campus Recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Swedish Medical Center
Cadence Pharmaceuticals
Investigators
Principal Investigator: Arthur Lam, MD, FRCPC Swedish Medical Center
  More Information

No publications provided

Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01474304     History of Changes
Other Study ID Numbers: IVAC, 20111619
Study First Received: November 9, 2011
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Medical Center:
craniotomy
tumor resection
aneurysm
revascularization
opioid
nausea
vomiting
acetaminophen

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on August 18, 2014