Pain, PostoperativePhase 1NCT05907213
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
A Phase 1 study testing Ketamine (Ketalar) Dose Level 1, Ketamine (Ketalar) Dose Level 2 and Ketamine (Ketalar) Dose Level 3 in people with Pain, Postoperative and Depression, Postpartum, run by Grace Lim, MD, MS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Depression, Postpartum
- What is being tested?
- Ketamine (Ketalar) Dose Level 1, Ketamine (Ketalar) Dose Level 2 and Ketamine (Ketalar) Dose Level 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 19 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)
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.
Read the 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.
- Conditions
- Pain, Postoperative, Depression, Postpartum
- Being tested
- Ketamine (Ketalar) Dose Level 1, Ketamine (Ketalar) Dose Level 2, Ketamine (Ketalar) Dose Level 3, Ketamine (Ketalar) Dose Level 4
- Keywords
- Cesarean Delivery
- Medical subject headings
- Pain, Postoperative, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (Ketalar) Dose Level 1Drug
Also called 0.05 mg/kg/1hr loading dose Ketamine
Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 2Drug
Also called 0.08 mg/kg/1hr loading dose Ketamine
Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 3Drug
Also called 0.12 mg/kg/1hr loading dose Ketamine
Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
Ketamine (Ketalar) Dose Level 4Drug
Also called 0.18 mg/kg/1hr loading dose Ketamine
Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ketamine (Ketalar) Dose Level 1 |
| 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 Receives: Drug: Ketamine (Ketalar) Dose Level 2 |
| 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 Receives: Drug: Ketamine (Ketalar) Dose Level 3 |
| 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 Receives: Drug: Ketamine (Ketalar) Dose Level 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 0 to 24 hours postpartum
Secondary outcomes (1)
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.
Measured: Between 0 to 24-hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Sep 2023
- Primary completion26 Jun 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- MTD 3+3 design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Lim, MD, MS
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Grace Lim, MD, MS, University of Pittsburgh
- Investigators
- Grace Lim, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907213
- Sponsor's protocol ID
- STUDY22100018
- Other IDs
- R01MH134538
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2023
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)
- ClinicalTrials.gov ID
- NCT05907213
- Acronym / sponsor ID
- STUDY22100018
- Conditions
- Pain, Postoperative, Depression, Postpartum
- Keywords
- Cesarean Delivery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Grace Lim, MD, MSUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- MTD 3+3 design
| Arm | Type | Receives |
|---|---|---|
| Ketamine (Ketalar) Dose Level 1 | Experimental | Drug: Ketamine (Ketalar) Dose Level 1Ketamine (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 | Drug: Ketamine (Ketalar) Dose Level 2Ketamine (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 | Experimental | Drug: Ketamine (Ketalar) Dose Level 3Ketamine (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 | Experimental | Drug: Ketamine (Ketalar) Dose Level 4Ketamine (Ketalar) Dose Level 4: Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- General anesthesia
- Allergy to study medications
- ASA PS 4 or higher
- Contraindications to neuraxial anesthesia
- Preterm delivery (<37 weeks gestation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine (Ketalar) Dose Level 1Also: 0.05 mg/kg/1hr loading dose KetamineLoading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours | Drug | Ketamine (Ketalar) Dose Level 1 |
| Ketamine (Ketalar) Dose Level 2Also: 0.08 mg/kg/1hr loading dose KetamineLoading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours | Drug | Ketamine (Ketalar) Dose Level 2 |
| Ketamine (Ketalar) Dose Level 3Also: 0.12 mg/kg/1hr loading dose KetamineLoading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours | Drug | Ketamine (Ketalar) Dose Level 3 |
| Ketamine (Ketalar) Dose Level 4Also: 0.18 mg/kg/1hr loading dose KetamineLoading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours | Drug | Ketamine (Ketalar) Dose Level 4 |
Primary outcome
Maximum Tolerated Dose of Ketamine
Time frame: Between 0 to 24 hours postpartum
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.
1 secondary outcome
Patient Reported Acceptability of Any Reported Side Effects
Time frame: Between 0 to 24-hours postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Lim, MD, MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine (Ketalar) Dose Level 1, Ketamine (Ketalar) Dose Level 2 and Ketamine (Ketalar) Dose Level 3 in people with Pain, Postoperative and Depression, Postpartum, run by Grace Lim, MD, MS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose of Ketamine (time frame: Between 0 to 24 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.