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CompletedPhase 1Results posted

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

NCT05907213 · Grace Lim, MD, MS

Closed to entry
Status
Not accepting participants
Phase 1
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Maximum Tolerated Dose of Ketamine

    Measured over Between 0 to 24 hours postpartum

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
FEMALE
Sex
Accepted
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

Where

1 study site

FacilityCityRegionCountry
Magee Womens Hospital of UPMCPittsburghPennsylvaniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05907213 on ClinicalTrials.gov →

Last updated in the registry 2025-09-12. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 2 trials from Grace Lim, MD, MS →