CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 0.6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04831736
NCT04831736Phase 4Completed

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

NYU Langone Health·interventional·Posted Apr 5, 2021·Updated May 16, 2023

In Brief

A Phase 4 clinical trial evaluating Ketamine and Placebo for Postoperative Pain. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedApr 5, 2021
Enrollment StartApr 26, 2021
Primary CompletionMar 29, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.2 years ago

Interventions

Ketaminedrug

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.

Placebodrug

Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.