Recruiting
Phase 1

Ketamine

Sponsor:

University of Utah

Code:

NCT06767566

Conditions

Pain

Postpartum Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ketamine (Ketalar)

Study Details

Brief summary:

The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics.

The peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.

Conditions

Pain

Postpartum Depression

Study ID

NCT06767566

Start date

Mar 28, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Peripartum Participants:

Inclusion Criteria

  • Cesarean delivery
  • Adults 18 years and older
  • Term delivery ≥ 37 weeks gestation anticipated at time of delivery
  • ASA PS 2 or 3
  • Able to provide informed consent
  • One of the following must be met for inclusion: Not planning to breastfeed OR ketamine use indicated for pain management plan.

Exclusion Criteria

  • Patient going under general anesthesia for cesarean delivery
  • Allergy to study medication (ketamine)
  • ASA PS 4 +
  • Contraindications to neuraxial anesthesia
  • Preterm delivery (<37 weeks gestation)
  • Anticipated fetal-neonatal complex care plan as indicated in the patient's chart
  • Patient history of ketamine or PCP abuse
  • Patient history of schizophrenia or psychosis
  • Patient history of liver or renal insufficiency
  • Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine
  • Participating in another pain or depression intervention trial
  • Undergoing hormonal or gender affirming therapies
  • Pre-eclampsia with severe features
  • Hemodynamic instability
  • Inability to participate in study procedures for any reason
  • Contraindicated medications use: oral antihypertensive medications (exclusion: hypertensive disorders of pregnancy), intravenous magnesium (exclusion: pre-eclampsia with severe features), ketamine/phencyclidine/psilocybins/any other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine/other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)

Control Participants

Inclusion Criteria

  • Age 18 years and older
  • Sex: Male or Female
  • Able to provide informed consent
  • ASA PS 1, 2, or 3

Exclusion Criteria

  • Allergy to study medication (ketamine)
  • ASA PS 4 +
  • Inability to participate in study procedures for any reason
  • Patient history of ketamine or PCP abuse
  • Patient history of schizophrenia or psychosis
  • Patient history of liver or renal insufficiency
  • Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine
  • Participating in another pain or depression intervention trial
  • Hemodynamic instability
  • Pregnant or pregnant within the last 6 weeks
  • Unwilling to provide urine sample for pregnancy testing (female controls)
  • Undergoing hormonal or gender affirming therapies
  • Contraindicated medications use: ketamine, phencyclidine, psilocybins, or other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine, or other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Ketamine Infusion: Cesarean Delivery Population

Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.

experimental: Ketamine Infusion: Healthy Control Population

Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.

Interventions

Ketamine (Ketalar)

Loading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours

Primary outcome measure

  • Maternal ketamine area under the curve (AUC) [ Time Frame: 0 to 24 hours from initiation of ketamine infusion ]

Central Contacts and Locations

Central contacts

Natalie Bennion, MPH

385-209-1185natalie.bennion@utah.edu

Amy Monroe, MPH, MBA

412-609-6161a.monroe@utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Natalie R Bennion, MPH

385-209-1185natalie.bennion@utah.edu

Amy Monroe, MPH, MBA

412-609-6161a.monroe@utah.edu

Principal Investigator:

Grace Lim, MD, MSc

More Information

Sponsor

University of Utah

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • Cesarean Delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of Utah on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.