Intravenous Acetaminophen for Craniotomy Patients (IVAC)

Swedish Medical Center

Status and phase: Unknown; Phase 2

Conditions: Craniotomy

Treatments: Drug: Acetaminophen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01474304

20111619 (Other Identifier)

IVAC

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Acetaminophen

Active Comparator group

Description:

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.

Treatment:

Drug: Acetaminophen

No acetaminophen

No Intervention group

Description:

Patients will receive standard of care with no intraoperative doses of acetaminophen.