drugset / Trial / NCT05037123
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
Phase 3
Active not recruiting
765 enrolled
NYU Langone Health
National Cancer Institute (NCI) · collab
RandomizedParallel-groupTriple-blindSupportive care
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).
Timeline
- Start
- 2022-01-04
- Primary completion
- 2025-05-28
- Completion
- 2026-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ketamine | Small molecule | 0.25 mg/kg | Intravenous |
| Comparator | Ketamine | Small molecule | 0.6 mg/kg | Intravenous |