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Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery
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:
🦠 Pain, Postoperative 🦠 Depression, Postpartum
🗓️ Study Start (Actual) 25 September 2023
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) July 2026
👥 Enrollment (Estimated) 12
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 June 2023
  • First Submitted that Met QC Criteria 7 June 2023
  • First Posted 18 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 February 2024
  • Last Update Posted 13 February 2024
  • Last Verified February 2024
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