Ketamine to Improve Recovery After Cesarean Delivery - Part 1
Status:
Completed
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1)
and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine
bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid
requirements. Physiochemical, PK/PD, and breastmilk transfer of ketamine and its metabolites,
as well as calculated estimations for neonatal and infant exposure will be assessed in Part
1. In Part 2, PK/PD assessments will continue in a larger cohort; endpoints will also include
postpartum pain, depression scores, central sensitization measures, patient-reported
postpartum recovery scores, breastfeeding, and parent-infant bonding, assessed in the acute
post-cesarean period and up to 12 weeks postpartum in Part 2.