NCT05907213

Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Grace Lim, MD, MS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative
• Depression, Postpartum

Interventions

Type	Name	Description
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
DRUG	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
DRUG	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
DRUG	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

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-06-26
• Completion: 2024-09-19
• First posted: 2023-06-18
• Last updated: 2025-09-12
• Results posted: 2025-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study