Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Key facts
- Who runs it
- University of Utah
- Where
- Pittsburgh and Salt Lake City, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 50 people, planned
- Started
- 30 Apr 2025
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Ketamine (Ketalar)
- Record updated
- 6 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 40 criteriaShow less
Who can take part
- 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
- Age 18 years and older
- Sex: Male or Female
- Able to provide informed consent
- ASA PS 1, 2, or 3
Who cannot take part
- Undergoing hormonal or gender affirming therapies
- Undergoing hormonal or gender affirming therapies
- Contraindicated medications use: ketamine, phencyclidine, psilocybins, or other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine, or other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)
- Allergy to study medication (ketamine)
- Patient history of ketamine or PCP abuse
- Patient history of schizophrenia or psychosis
- Patient history of liver or renal insufficiency
- Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine
- Allergy to study medication (ketamine)
- Patient history of ketamine or PCP abuse
- Patient history of schizophrenia or psychosis
- Patient history of liver or renal insufficiency
- Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine
- Contraindicated medications use: oral antihypertensive medications (exclusion: hypertensive disorders of pregnancy), intravenous magnesium (exclusion: pre-eclampsia with severe features), ketamine/phencyclidine/psilocybins/any other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine/other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis); Control Participants
- Patient going under general anesthesia for cesarean delivery
- ASA PS 4 +
- Contraindications to neuraxial anesthesia
- Preterm delivery (<37 weeks gestation)
- Anticipated fetal-neonatal complex care plan as indicated in the patient's chart
- Participating in another pain or depression intervention trial
- Pre-eclampsia with severe features
- Hemodynamic instability
- Inability to participate in study procedures for any reason
- ASA PS 4 +
- Inability to participate in study procedures for any reason
- Participating in another pain or depression intervention trial
- Hemodynamic instability
- Pregnant or pregnant within the last 6 weeks
- Unwilling to provide urine sample for pregnancy testing (female controls)
Other criteria
- Peripartum Participants:
Where in United States
- Magee-Womens Hospital of UPMCPittsburgh, United StatesContact: Natalie Bennion, MPHNo longer taking part
- University of UtahSalt Lake City, United StatesContact: Natalie R Bennion, MPHTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Ketamine Infusion: Cesarean Delivery PopulationTreatment being tested
Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.
Treatment: Ketamine (Ketalar)
- Ketamine Infusion: Healthy Control PopulationTreatment being tested
Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.
Treatment: Ketamine (Ketalar)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 6 November 2026