DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Intravenous Acetaminophen for Craniotomy Patients

Information source: Swedish Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Craniotomy

Intervention: Acetaminophen (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Swedish Medical Center

Official(s) and/or principal investigator(s):
Arthur Lam, MD, FRCPC, Principal Investigator, Affiliation: Swedish Medical Center

Overall contact:
Becky Wood, Phone: 206-320-7115, Email: becky.wood@swedish.org

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.

Clinical Details

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

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

Secondary outcome:

Incidence of nausea during postoperative recovery

Incidence of vomiting during postoperative recovery

Severity of nausea during postoperative recovery

Severity of vomiting during postoperative recovery

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Becky Wood, Phone: 206-320-7115, Email: becky.wood@swedish.org

Swedish Medical Center Cherry Hill Campus, Seattle, Washington 98122, United States; Recruiting
Additional Information

Starting date: November 2011
Last updated: June 4, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017