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Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
Sponsor: NYU Langone Health
Summary
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine).
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
765
Start Date
2022-01-04
Completion Date
2026-08-31
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
Continuous ketamine infusion
Continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.25 mg/kg/hr until 2 hours after surgery) plus saline IV dose in post-anesthesia care unit
Ketamine + Saline
Saline dose and infusion intraoperatively, then single-dose IV ketamine (0.60 mg/kg) in post-anesthesia care unit plus 2 hours of saline administration after surgery
Placebo
Placebo, Saline dose and infusion intraoperatively, then saline IV dose in post-anesthesia care unit plus 2 hours of saline administration after surgery
Locations (14)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arkansas
Little Rock, Arkansas, United States
Rush University Medical Center
Chicago, Illinois, United States
Brigham and Women's Hospital - Harvard University
Chestnut Hill, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University at St. Louis Medical Center
St Louis, Missouri, United States
NYU Langone Health (Tisch Hospital, Kimmel Pavilion)
New York, New York, United States
New York Presbyterian Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center - Albert Einstein College of Medicine
The Bronx, New York, United States
University of Pittsburgh - Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
University of Texas - Southwestern Medical Center
Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States