IVAC: Intravenous Acetaminophen for Craniotomy Patients

Sponsor

Swedish Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01474304

Collaborator

Mallinckrodt (Industry)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Craniotomy	Drug: Acetaminophen	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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