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

Grace Lim, MD, MS

Status and phase

Completed

Phase 1

Conditions

Depression, Postpartum

Pain, Postoperative

Treatments

Drug: Ketamine (Ketalar) Dose Level 2

Drug: Ketamine (Ketalar) Dose Level 3

Drug: Ketamine (Ketalar) Dose Level 4

Drug: Ketamine (Ketalar) Dose Level 1

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05907213

STUDY22100018

R01MH134538 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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