NCT04831736

Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy

Randomized, Single-blind, Placebo-controlled Study on the Effect of Postoperative Administration of Single Dose Ketamine After Mastectomy on Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy. The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0.
DRUG	Placebo	Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.

Timeline

• Start date: 2021-04-26
• Primary completion: 2022-03-29
• Completion: 2022-03-29
• First posted: 2021-04-05
• Last updated: 2023-05-16
• Results posted: 2023-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study