RecruitingPhase 1NCT06767566

Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery


Sponsor

Grace Lim, MD, MS

Enrollment

50 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics. The peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how ketamine (a medication used for pain and sometimes depression) behaves in the body after a cesarean delivery, and whether it can help with both postpartum depression and post-surgical pain in new mothers. **You may be eligible if...** - You are 18 or older and planning to have a cesarean delivery (C-section) - Your delivery is expected at 37 weeks or later (full term) - You do not plan to breastfeed, OR your doctor has determined ketamine is needed for your pain management - You are classified as ASA physical status 2 or 3 (meaning you have mild to moderate health conditions) **You may NOT be eligible if...** - You are having your C-section under general anesthesia - You have an allergy to ketamine - You have a history of ketamine or PCP abuse - Your baby is expected to need complex neonatal care - You have severe health conditions (ASA PS 4 or higher) - You plan to breastfeed and ketamine is not clinically indicated for your pain Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine (Ketalar)

Loading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours


Locations(2)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

UPMC Montefiore Clinical and Translational Research Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06767566


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