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Intravenous Acetaminophen for Post-Craniotomy Pain Management (IVAC Trial)

Phase 2

Waitlist Available

Led By Arthur Lam, MD, FRCPC

Research Sponsored by Swedish Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4

Weigh at least 50 kg (110.23 lbs)

Must not have

Current daily opioid use (>40 mg morphine equivalent)

Tramadol use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 hours

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial found that giving acetaminophen during surgery, in addition to standard painkillers, decreased the amount of opioids needed in the 12 hours after surgery. Since opioids can worsen nausea and vomiting, this may reduce the incidence of these symptoms in patients after craniotomy.

Who is the study for?

This trial is for adults over 18, weighing at least 50 kg, undergoing elective craniotomy for tumor removal, aneurysm clipping or revascularization with a moderate health status (ASA 1-4). Excluded are those with significant diseases, daily opioid use, recent MAO inhibitors or acetaminophen use, liver issues, pregnancy, substance abuse history or participation in another study within the last month.

What is being tested?

The trial tests if giving IV acetaminophen during surgery reduces the need for opioids and lessens nausea and vomiting after craniotomy. It's added to standard painkillers and compared to usual care without IV acetaminophen over the first 12 postoperative hours.

What are the potential side effects?

While generally safe when used as directed, potential side effects of IV acetaminophen include allergic reactions like rash or itching. Overuse can lead to liver damage especially in people with pre-existing liver conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My health is rated between 1 to 4 on the ASA scale.

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I weigh at least 110 pounds.

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I am scheduled for an open brain surgery for tumor removal or to address an aneurysm or blood flow issues.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use more than 40 mg of opioids daily.

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I use tramadol.

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I am allergic to acetaminophen.

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I have had surgery to remove a tumor through my nose.

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My liver isn't working properly.

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I have had surgery to remove an acoustic neuroma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: AcetaminophenActive Control1 Intervention

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.

Group II: No acetaminophenActive Control1 Intervention

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

0 / 10Eligibility criteria met