Intravenous Acetaminophen for Craniotomy Patients (IVAC)

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.

Study Overview

• Status: Unknown
• Conditions: Craniotomy
• Intervention / Treatment: Drug: Acetaminophen

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98122
      • Recruiting
      • Swedish Medical Center Cherry Hill Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total narcotic dose administered over the first 12 hours of postoperative recovery.	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.	12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of nausea during postoperative recovery	12 hours
Incidence of vomiting during postoperative recovery	12 hours
Severity of nausea during postoperative recovery	12 hours
Severity of vomiting during postoperative recovery	12 hours

Collaborators and Investigators

• Sponsor: Swedish Medical Center
• Collaborators: Mallinckrodt
• Investigators: Principal Investigator: Arthur Lam, MD, FRCPC, Swedish Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: September 27, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: opioid; nausea; acetaminophen; vomiting; aneurysm; craniotomy; revascularization; tumor resection
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: IVAC; 20111619 (Other Identifier: Western Institutional Review Board (WIRB))