Clinical Trial

Ketamine to Improve Recovery After Cesarean Delivery

Study Description

Ketamine to Improve Recovery After Cesarean Delivery - Part 1

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 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Ketamine

Subjects in the intervention arm will receive bolus and infusion dosing as noted in arm/group descriptions at the time of cord clamping. Duration of infusion will be 12 hours. Breastmilk, maternal serum and urine, side effects, adverse events, and efficacy endpoints will be measured over the 12 hour infusion and over 15 hours after infusion discontinuation.

Additional Information

Official Study Title

Evaluation of PK/PD, Breastmillk Transfer, and Effectiveness of Ketamine After Cesarean Delivery - Part 1

Clinical Trial ID

NCT04037085

ParticipAid ID

dBBAkd