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Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT05907213
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : February 13, 2024
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Grace Lim, MD, MS, University of Pittsburgh

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Depression, Postpartum Drug: Ketamine (Ketalar) Dose Level 1 Drug: Ketamine (Ketalar) Dose Level 2 Drug: Ketamine (Ketalar) Dose Level 3 Drug: Ketamine (Ketalar) Dose Level 4 Phase 1

Detailed Description:
Pain management for women having a cesarean delivery is rather limited and risks poor pain control, depressed mood, and poor recovery following the cesarean delivery. Current cesarean pain management treatments ignore the multidimensionality of pain, including the influence of mood on pain. Recent evidence suggests that ketamine may provide successful post-surgical pain management, opioid reduction, and rapid reduction of depressive symptoms. The current study aims to identify an appropriate dose of ketamine for post-cesarean pain management while minimizing potential dose-dependent side effects in women following childbirth.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: MTD 3+3 design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)
Actual Study Start Date : September 25, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Loading dose Ketamine
Loading dose of ketamine in 3+3 MTD for 1 hour followed by maintenance 0.05mg/kg/hr ketamine 11-hour infusion.
 Drug: 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
Other Name: 0.05 mg/kg/1hr loading dose Ketamine

Drug: 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
Other Name: 0.08 mg/kg/1hr loading dose Ketamine

Drug: 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
Other Name: 0.12 mg/kg/1hr loading dose Ketamine

Drug: 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 Name: 0.18 mg/kg/1hr loading dose Ketamine


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose of ketamine [ Time Frame: Between 0 to 24 hours postpartum ]
    Dose that fewer than 33% of patients experience intolerability


Secondary Outcome Measures :
  1. Patient reported acceptability of any reported side effects [ Time Frame: Between 0 to 24-hours postpartum ]
    Proportion (%) of patient cohort reporting acceptability at each ketamine dose


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05907213


Contacts
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Contact: Amy Monroe, MPH, MBA 4126236382 monroeal@upmc.edu

Locations
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United States, Pennsylvania
Magee Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Minhnoi Wroble Biglan, PhD    412-641-1777    wroblebiglanm@upmc.edu   
Contact: Amy Monroe    4126236382    monroeal@upmc.edu   
Principal Investigator: Grace Lim, MD, MSc         
Sponsors and Collaborators
Grace Lim, MD, MS
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Grace Lim, MD, MSc University of Pittsburgh
More Information
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Responsible Party: Grace Lim, MD, MS, Associate Professor, Chief Obstetric & Women's Anesthesiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT05907213    
Other Study ID Numbers: STUDY22100018
1R01MH134538-01 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be available for public benefit and knowledge. Items for uploading will include clinical measures, patient reported outcomes, psychometric testing data, sensory testing data, and all PK data. Technical protocols and any other data collected under this project will be shared upon request to allow others to perform secondary analyses.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Beginning with 3 months and ending at 5 years following article publication.
Access Criteria: Researchers who propose a methodologically sound proposal may submit said proposals to limkg2@upmc.edu. To gain access to data, requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Grace Lim, MD, MS, University of Pittsburgh:
Cesarean Delivery
Additional relevant MeSH terms:
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Ketamine
Depression, Postpartum
Pain, Postoperative
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Puerperal Disorders
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action