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ACTIVE NOT RECRUITING
NCT05037123
PHASE3

Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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

OTHER

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