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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Craniotomy

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Total narcotic dose administered over the first 12 hours of postoperative recovery.

Outcome Description:

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.

Outcome Time Frame:

12 hours

Safety Issue:

No

Principal Investigator

Arthur Lam, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Swedish Medical Center

Authority:

United States: Institutional Review Board

Study ID:

IVAC

NCT ID:

NCT01474304

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Craniotomy
  • craniotomy
  • tumor resection
  • aneurysm
  • revascularization
  • opioid
  • nausea
  • vomiting
  • acetaminophen

Name

Location

Swedish Medical Center Cherry Hill CampusSeattle, Washington  98122