Phase 1
Completed N=12
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
Pain, Postoperative · Depression, Postpartum
Source: ClinicalTrials.gov NCT05907213 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Maximum Tolerated Dose of Ketamine — 3; 3; 3; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Ketamine |
3; 3; 3; 3; 0; 0 | — |
| SECONDARY Patient Reported Acceptability of Any Reported Side Effects |
3; 2; 3; 3; 0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT05907213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.