Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery (PREPARE-2)

This Phase I interventional trial (n=50) will study the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the drug’s effects on the body) of ketamine in postpartum women following a caesarean delivery. Participants will receive a ketamine infusion (12.6mg/70kg/hr for 1 hour, followed by 3.5mg/70kg/hr for 11 hours) to assess how the drug is metabolised and its potential role in managing post-surgical pain and postpartum depression.

The study, led by Dr Grace Lim at the University of Pittsburgh, will also compare ketamine metabolism in postpartum women to that of non-pregnant female and male controls receiving the same dosing protocol. This research aims to address gaps in understanding ketamine’s effectiveness and metabolism in postpartum pain management and mood regulation. Outcomes will include measuring ketamine concentration in blood samples, assessing patient-reported side effects, and evaluating pain and depression scores over 12 weeks.

Trial Details

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 consiste of non-pregnant female subjects and male subjects receiving the same infusion protocol.

Trial Number NCT06767566

Data attribution

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