Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
NCT ID: NCT05907213
Last Updated: 2025-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2023-09-25
2024-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Ketamine (Ketalar) Dose Level 1
Ketamine (Ketalar) Dose Level 1: Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 1
Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 2
Ketamine (Ketalar) Dose Level 2: Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 2
Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 3
Ketamine (Ketalar) Dose Level 3: Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 3
Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 4
Ketamine (Ketalar) Dose Level 4: Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 4
Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Interventions
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Ketamine (Ketalar) Dose Level 1
Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 2
Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 3
Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 4
Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Grace Lim, MD, MS
OTHER
Responsible Party
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Grace Lim, MD, MS
Associate Professor, Chief Obstetric & Women's Anesthesiology
Principal Investigators
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Grace Lim, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY22100018
Identifier Type: -
Identifier Source: org_study_id
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