Intravenous Acetaminophen for Craniotomy Patients

Craniotomy Clinical Trial

— IVAC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01474304
• Other study ID #: IVAC
• Secondary ID: 20111619
• Status: Recruiting
• Phase: Phase 2
• First received: November 9, 2011
• Last updated: September 27, 2016
• Start date: November 2011

Study information

• Verified date: September 2016
• Source: Swedish Medical Center
• Contact: Becky Wood
• Phone: 206-320-7115
• Email: becky.wood[@]swedish.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Craniotomy

Intervention

Drug:
• Acetaminophen
1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery

Locations

Country	Name	City	State
United States	Swedish Medical Center Cherry Hill Campus	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Swedish Medical Center	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of nausea during postoperative recovery		12 hours	No
Secondary	Incidence of vomiting during postoperative recovery		12 hours	No
Secondary	Severity of nausea during postoperative recovery		12 hours	No
Secondary	Severity of vomiting during postoperative recovery		12 hours	No