CompletedPhase 1ketamine

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

NCT ID

NCT05907213

Target Enrollment

12 participants

Start Date

2023-09-25

Est. Completion

2024-09-19

About This Study

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.

Conditions Studied

Pain, PostoperativeDepression, Postpartum

Interventions

•Ketamine (Ketalar) Dose Level 1
•Ketamine (Ketalar) Dose Level 2
•Ketamine (Ketalar) Dose Level 3
•Ketamine (Ketalar) Dose Level 4

Eligibility

Sex:FEMALE

Age:18 Years - N/A

Healthy Volunteers:Yes

View full eligibility criteria

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

Study Locations (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States