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

Launched by GRACE LIM, MD, MS · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how ketamine, a medication that can help with pain and depression, behaves in the body of women who have just given birth via cesarean delivery. The researchers want to understand how ketamine is processed and its effects specifically in postpartum women, compared to non-pregnant individuals. This is important because the body goes through many changes during and after pregnancy, which might affect how medications work. Participants who have had a cesarean section and meet specific health criteria may be eligible to join the study.

If you are part of the postpartum group, you will receive ketamine after your cesarean delivery to help manage pain. There is also a control group that includes non-pregnant women and men receiving the same treatment for comparison. Participants will need to provide informed consent and meet certain health requirements, such as not having serious allergies to ketamine or specific health conditions. This study is currently looking for volunteers, and your participation could help improve understanding of how to better treat pain and depression after childbirth.

Gender

ALL

Eligibility criteria

• 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 complex care plan as indicated in the patient's chart
• • 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
• • Participating in another pain or depression intervention trial
• • Undergoing hormonal or gender affirming therapies
• • Pre-eclampsia with severe features
• • Hemodynamic instability
• • Inability to participate in study procedures for any reason
• • 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
• • Inclusion Criteria
• • Age 18 years and older
• • Sex: Male or Female
• • Able to provide informed consent
• • ASA PS 1, 2, or 3
• • Exclusion Criteria
• • Allergy to study medication (ketamine)
• • ASA PS 4 +
• • Inability to participate in study procedures for any reason
• • 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
• • 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)
• • 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)