Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery

Pain, Postoperative Clinical Trial

Official title:

Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907213
• Other study ID #: STUDY22100018
• Secondary ID: 1R01MH134538-01
• Status: Recruiting
• Phase: Phase 1
• Start date: September 25, 2023
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Amy Monroe, MPH, MBA
• Phone: 4126236382
• Email: monroeal[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Pain, Postoperative

Intervention

Drug:
• 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
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
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
Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours

Locations

Country	Name	City	State
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Grace Lim, MD, MS	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose of ketamine	Dose that fewer than 33% of patients experience intolerability	Between 0 to 24 hours postpartum
Secondary	Patient reported acceptability of any reported side effects	Proportion (%) of patient cohort reporting acceptability at each ketamine dose	Between 0 to 24-hours postpartum