Intravenous Acetaminophen for Craniotomy Patients

Phase 2

• Conditions: Craniotomy
• Interventions: Drug: Acetaminophen

• Registration Number: NCT01474304
• Lead Sponsor: Swedish Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-18
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-29
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Swedish Medical Center Cherry Hill Campus; 🇺🇸 Seattle, Washington, United States