Ketamine Clinical Trials
Evaluation of PK/PD, Breastmilk Transfer, and Effectiveness of Ketamine After Cesarean Delivery - Part 1
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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
Total execution time in seconds: 0.30660915374756