CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Ketamine (Ketalar) Dose Level 1 +3 moredrug
Likely dose
Ketamine (Ketalar) Dose Level 1 0.05 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05907213
NCT05907213Phase 1Completed
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Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)

Grace Lim, MD, MS·interventional·Posted Jun 18, 2023·Updated Sep 12, 2025

In Brief

A Phase 1 clinical trial evaluating Ketamine (Ketalar) Dose Level 1, Ketamine (Ketalar) Dose Level 2, and 2 other interventions for Pain, Postoperative and Depression, Postpartum. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative, Depression, Postpartum
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 1CompletedFinished
202420252026
First PostedJun 18, 2023
Enrollment StartSep 25, 2023
Primary CompletionJun 26, 2024
Study CompletionSep 19, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.0 years ago

Interventions

Ketamine (Ketalar) Dose Level 1drug

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

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

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

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