Clinical trial NCT05907213: Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
Official title: Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain, Postoperative
Depression, Postpartum
Keywords: Cesarean Delivery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-06-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: MTD 3+3 design
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Maximum Tolerated Dose of ketamine
timeFrame: Between 0 to 24 hours postpartum
Secondary outcomes:
measure: Patient reported acceptability of any reported side effects
timeFrame: Between 0 to 24-hours postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Grace Lim, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: