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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH134538 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine (Ketalar) Dose Level 1 | Experimental | 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 | Experimental | 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 |
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| Ketamine (Ketalar) Dose Level 3 | Experimental | 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 |
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| Ketamine (Ketalar) Dose Level 4 | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine (Ketalar) Dose Level 1 | Drug | Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Ketamine | Maximum tolerated dose of ketamine is measured by dose that fewer than 33% of patients experience a dose-limiting toxicity (DLT) defined by intolerability. Tolerability will be defined as: lack of adverse events (adverse event defined as: severe unresolved hemodynamic effect: systolic blood pressure <80 or >160, heart rate <40 or >120). Intolerability will be defined as presence of any adverse event (i.e., severe unresolved hemodynamic effect: systolic blood pressure <80 or >160, heart rate <40 or >120). Outcome measure of tolerability and intolerability will be reported as n (%). The MTD was 0.18 mg/kg/hr for one hour, followed by 0.05 mg/kg/hr for 11 hours. | Between 0 to 24 hours postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Acceptability of Any Reported Side Effects | Number (%) of patient cohort reporting acceptability at each ketamine dose. Patient reported acceptability was recorded from a 21-question survey that reviewed seven common side effects: dizziness, lightheadedness, bad dreams, hallucinations, nausea, vomiting, and itchiness. Unacceptability is defined as patients reporting any of seven side effects as unacceptable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Lim, MD, MSc | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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.
Beginning with 3 months and ending at 5 years following article publication.
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Ketamine (Ketalar) Dose Level 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2024 |
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MTD 3+3 design
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| Ketamine (Ketalar) Dose Level 2 | Drug | Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours |
|
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| Ketamine (Ketalar) Dose Level 3 | Drug | Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours |
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| Ketamine (Ketalar) Dose Level 4 | Drug | Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours |
|
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| Between 0 to 24-hours postpartum |
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
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Estimated Gestational Age at Delivery | Count of Participants | Participants |
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| History of Anxiety | Count of Participants | Participants |
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| History of Depression | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose of Ketamine | Maximum tolerated dose of ketamine is measured by dose that fewer than 33% of patients experience a dose-limiting toxicity (DLT) defined by intolerability. Tolerability will be defined as: lack of adverse events (adverse event defined as: severe unresolved hemodynamic effect: systolic blood pressure <80 or >160, heart rate <40 or >120). Intolerability will be defined as presence of any adverse event (i.e., severe unresolved hemodynamic effect: systolic blood pressure <80 or >160, heart rate <40 or >120). Outcome measure of tolerability and intolerability will be reported as n (%). The MTD was 0.18 mg/kg/hr for one hour, followed by 0.05 mg/kg/hr for 11 hours. | Posted | Count of Participants | Participants | Between 0 to 24 hours postpartum |
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| Secondary | Patient Reported Acceptability of Any Reported Side Effects | Number (%) of patient cohort reporting acceptability at each ketamine dose. Patient reported acceptability was recorded from a 21-question survey that reviewed seven common side effects: dizziness, lightheadedness, bad dreams, hallucinations, nausea, vomiting, and itchiness. Unacceptability is defined as patients reporting any of seven side effects as unacceptable. | Posted | Count of Participants | Participants | Between 0 to 24-hours postpartum |
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Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | 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 | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 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 | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | 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 | 0 | 3 | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side effect: Itchiness | Social circumstances | Non-systematic Assessment | Patient reported itchiness |
| |
| Side effect: Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment | Patient reported nausea and/or vomiting |
| |
| Side effect: Dizziness or lightheadedness | Gastrointestinal disorders | Non-systematic Assessment | Patient reported dizziness and/or lightheadedness |
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| LSD Dysphoria Scale Score | Psychiatric disorders | Non-systematic Assessment | LSD scale is used occasionally as an indicator of dysphoria (negative mood or confusion) - patient reported score of >8. |
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| Bad Dreams | Psychiatric disorders | Non-systematic Assessment |
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| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Grace Lim, Chief of the Division of OB & Women's Anesthesiology | University of Pittsburgh, UPMC Department of Anesthesiology & Perioperative Medicine | 412-641-1778 | limkg2@upmc.edu |
| Jun 9, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2024 | Jun 11, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 38-weeks |
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| 39-weeks |
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| 40-weeks |
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| Intolerability of Dose |
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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
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