CompletedPhase 1

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

United States12 participantsStarted 2023-09-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Tolerated Dose of Ketamine

Timeframe: Between 0 to 24 hours postpartum

Trial details

NCT IDNCT05907213

SponsorGrace Lim, MD, MS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-26

Results submitted2025-06-26

View on ClinicalTrials.gov More Pain, Postoperative trials