Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Grace Lim, MD, MS
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.
Description
A lack of data on new pain treatments in pregnancy puts 1.2 million US women having cesarean delivery (CD) every year at risk for poor pain control, depressed mood, and poor recovery. Evidence of successful post-surgical pain management and rapid reduction of depressive symptoms render ketamine a great candidate for post-CD pain management and potential reduction of postpartum depression (PPD) symptomology. Knowledge gaps in ketamine pharmacokinetics (PK) in the postpartum period limit an informed approach to its use for postpartum analgesia and PPD mitigation strategies. Similarly, knowledge…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Peripartum Participants: Inclusion Criteria * Cesarean delivery * Adults 18 years and older * Term delivery ≥ 37 weeks gestation anticipated at time of delivery * ASA PS 2 or 3 * Able to provide informed consent * One of the following must be met for inclusion: Not planning to breastfeed OR ketamine use indicated for pain management plan. Exclusion Criteria * Patient going under general anesthesia for cesarean delivery * Allergy to study medication (ketamine) * ASA PS 4 + * Contraindications to neuraxial anesthesia * Preterm delivery (\<37 weeks gestation) * Anticipated fetal-neonatal comp…
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 UPMCPittsburgh, Pennsylvania
- UPMC Montefiore Clinical and Translational Research CenterPittsburgh, Pennsylvania