Ketamine molecule:

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Ketamine Clinical Trials


Evaluation of PK/PD, Breastmilk 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: December 20, 2022

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.

In Part 1, physiochemical analysis of pharmacokinetic/pharmacodynamic (PK/PD) and breastmilk transfer of ketamine and its metabolites will be assessed. Additionally calculated estimations for neonatal and infant exposure will be assessed.

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 a randomized controlled trial.

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


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