Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery (PREPARE-2)
Phase I interventional study (n=50) comparing ketamine pharmacokinetics and pharmacodynamics in postpartum cesarean patients versus healthy controls using a 12-hour infusion (0.18 mg/kg/hr x1 h loading then 0.05 mg/kg/hr x11 h maintenance).
Details
This study characterises ketamine pharmacokinetics and pharmacodynamics in postpartum women after cesarean delivery and compares kinetics to non-pregnant female and male controls receiving the same 12-hour infusion.
Primary objective is to define ketamine PK in the post‑delivery physiologic state; secondary objectives include comparison with reproductive age matched controls and assessment of sex differences in metabolism.
Peripartum participants receive a loading infusion for 1 hour followed by an 11‑hour maintenance infusion beginning after cord clamping; blood sampling will define PK parameters and PD measures.