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Ketamine Clinical Trials

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

To see complete record on clinicaltrials.gov, please visit this link

Id: NCT04037085

Organisation Name: University of Pittsburgh

Overal Status: Completed

Start Date: October 9, 2019

Last Update: October 5, 2021

Lead Sponsor: Grace Lim, MD, MS

Brief 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.

• Obstetric Pain
• Postpartum Depression
• Breastfeeding
• Pain, Acute
• Pain, Chronic
• Obstetric Anesthesia Problems
• Drug Effect
• Opioid Use