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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 hours

Awards & highlights

IVAC Trial 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.Check my eligibility

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.See study design

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.

IVAC Trial 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.

IVAC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Incidence of nausea during postoperative recovery

Incidence of vomiting during postoperative recovery

Severity of nausea during postoperative recovery

+1 more

IVAC 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Swedish Medical CenterLead Sponsor

53 Previous Clinical Trials

8,214 Total Patients Enrolled

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

16,148 Total Patients Enrolled

Arthur Lam, MD, FRCPCPrincipal InvestigatorSwedish Medical Center

Media Library

Acetaminophen Clinical Trial Eligibility Overview. Trial Name: NCT01474304 — Phase 2

Craniotomy Clinical Trial 2023: Acetaminophen Highlights & Side Effects. Trial Name: NCT01474304 — Phase 2

Acetaminophen 2023 Treatment Timeline for Medical Study. Trial Name: NCT01474304 — Phase 2

Craniotomy Research Study Groups: Acetaminophen, No acetaminophen

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other investigations been conducted concerning Acetaminophen?

"Presently, 89 experiments are being conducted for Acetaminophen. Of these, 26 are in the advanced Phase 3 stage and 1003 research sites exist across America with Pittsburgh Pennsylvania at their epicentre."

Answered by AI

Is enrollment still available for those who are interested in participating in this experiment?

"This clinical trial has concluded enrollment, with its initial posting being on November 1st 2011 and the last update taking place on September 27th 2016. For those searching for substitute studies there are 3 craniotomy trials actively recruiting patients as well as 89 Acetaminophen related trials that are welcoming participants."

Answered by AI

What maladies is Acetaminophen typically employed to remedy?

"Catarrh is commonly addressed using Acetaminophen, which is also beneficial in treating rhinorrhoea, musculoskeletal pain and muscle contractions."

Answered by AI

What is the total capacity of this clinical investigation?

"This research project is presently not recruiting. The trial was initially made available on November 1st 2011 and most recently revised on September 27th 2016. If you are in search of other studies, there are 3 trials currently enrolling patients with craniotomy and 89 clinical studies using Acetaminophen that need participants."

Answered by AI

What deleterious effects can result from taking Acetaminophen?

"The team at Power gave Acetaminophen a rating of 2 on the safety scale due to its Phase 2 status, suggesting that limited data exists in support of both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravenous Acetaminophen for Craniotomy Patients

2011. "Intravenous Acetaminophen for Craniotomy Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01474304.

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