Back to resultsKetamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery
Primary Purpose
Pain, Postoperative, Depression, Postpartum
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine (Ketalar) Dose Level 1
Ketamine (Ketalar) Dose Level 2
Ketamine (Ketalar) Dose Level 3
Ketamine (Ketalar) Dose Level 4
Sponsored by
About this trial
This is an interventional other trial for Pain, Postoperative focused on measuring Cesarean Delivery
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
Sites / Locations
- Magee Womens Hospital of UPMCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Loading dose Ketamine
Arm Description
Loading dose of ketamine in 3+3 MTD for 1 hour followed by maintenance 0.05mg/kg/hr ketamine 11-hour infusion.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose of ketamine
Dose that fewer than 33% of patients experience intolerability
Secondary Outcome Measures
Patient reported acceptability of any reported side effects
Proportion (%) of patient cohort reporting acceptability at each ketamine dose
Full Information
NCT ID
NCT05907213
First Posted
June 7, 2023
Last Updated
October 3, 2023
Sponsor
Grace Lim, MD, MS
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05907213
Brief Title
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery
Official Title
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Grace Lim, MD, MS
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Depression, Postpartum
Keywords
Cesarean Delivery
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
MTD 3+3 design
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Loading dose Ketamine
Arm Type
Experimental
Arm Description
Loading dose of ketamine in 3+3 MTD for 1 hour followed by maintenance 0.05mg/kg/hr ketamine 11-hour infusion.
Intervention Type
Drug
Intervention Name(s)
Ketamine (Ketalar) Dose Level 1
Other Intervention Name(s)
0.05 mg/kg/1hr loading dose Ketamine
Intervention Description
Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Intervention Type
Drug
Intervention Name(s)
Ketamine (Ketalar) Dose Level 2
Other Intervention Name(s)
0.08 mg/kg/1hr loading dose Ketamine
Intervention Description
Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Intervention Type
Drug
Intervention Name(s)
Ketamine (Ketalar) Dose Level 3
Other Intervention Name(s)
0.12 mg/kg/1hr loading dose Ketamine
Intervention Description
Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Intervention Type
Drug
Intervention Name(s)
Ketamine (Ketalar) Dose Level 4
Other Intervention Name(s)
0.18 mg/kg/1hr loading dose Ketamine
Intervention Description
Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose of ketamine
Description
Dose that fewer than 33% of patients experience intolerability
Time Frame
Between 0 to 24 hours postpartum
Secondary Outcome Measure Information:
Title
Patient reported acceptability of any reported side effects
Description
Proportion (%) of patient cohort reporting acceptability at each ketamine dose
Time Frame
Between 0 to 24-hours postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minhnoi C Wroble Biglan, PhD
Phone
14126411177
Email
wroblebiglanm@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy C Monroe, MS
Phone
4126236382
Email
monroeal@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Lim, MD, MSc
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minhnoi Wroble Biglan, PhD
Phone
412-641-1777
Email
wroblebiglanm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Amy Monroe
Phone
4126236382
Email
monroeal@upmc.edu
First Name & Middle Initial & Last Name & Degree
Grace Lim, MD, MSc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Beginning with 3 months and ending at 5 years following article publication.
IPD Sharing 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.
Learn more about this trial
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery
We'll reach out to this number within 24 hrs