Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)

Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)

The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design. A loading dose over 1 hour will be the MTD variable to be tested, as our data suggest that ketamine side effects occur with the loading dose. The investigators hypothesize that subanesthetic ketamine dose will be well tolerated and any noted side effects will be rated acceptable by postpartum women following cesarean delivery.

Pain management for women having a cesarean delivery is rather limited and risks poor pain control, depressed mood, and poor recovery following the cesarean delivery. Current cesarean pain management treatments ignore the multidimensionality of pain, including the influence of mood on pain. Recent evidence suggests that ketamine may provide successful post-surgical pain management, opioid reduction, and rapid reduction of depressive symptoms. The current study aims to identify an appropriate dose of ketamine for post-cesarean pain management while minimizing potential dose-dependent side effects in women following childbirth.

Inclusion Criteria:

• Adults 18 years and older
• Cesarean Delivery
• American Society of Anesthesiologists Physical Status of 2 or 3
• Neuraxial anesthesia with neuraxial morphine
• Term delivery ≥37 weeks gestation
• Either planning not to breastfeed, OR receiving ketamine as part of routine clinical care

Exclusion Criteria:

• General anesthesia
• Allergy to study medications
• ASA PS 4 or higher
• Contraindications to neuraxial anesthesia
• Preterm delivery (<37 weeks gestation)
• Anticipated fetal-neonatal complex care plan
• Participating in another pain intervention trial
• Hypertensive disorder of pregnancy
• Pre-eclampsia with severe features
• Hemodynamic instability
• Medical History exclusions: ketamine or PCP (phencyclidine) abuse, schizophrenia or psychosis, liver or renal insufficiency, uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled thyroid disease, or other contraindications to ketamine