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Pharmacokinetics of Ketamine in Lactating Women

Shahane, Aditi Dhananjay (2022) Pharmacokinetics of Ketamine in Lactating Women. Master's Thesis, University of Pittsburgh. (Unpublished)

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Ketamine is a unique dissociative non-opioid analgesic with a better side-effect profile than opioids. It is commonly prescribed peri-operatively for moderate to severe, acute, and chronic pain management. According to recent guidelines published in 2018, use of ketamine is to be avoided during pregnancy. This is due to lack of data regarding safety of ketamine in this patient population. However, there is an increasing interest in using ketamine for pain management using multimodal pain management strategy after cesarean deliveries. It is essential to confirm the safety and efficacy of ketamine in this patient population. Unfortunately, there is lack of data regarding maternal pharmacokinetics of ketamine during pregnancy and post-partum. Literature on drug exposure to the infant during lactation is also unavailable. In the current study, we aimed to gather more data on lactating maternal pharmacokinetics as well as the amount of drug that is excreted in human milk and is available for consumption by the infant.
A clinical study was performed to evaluate ketamine pharmacokinetics and assessing infant drug exposure when ketamine is intravenously administered to lactating women. Plasma and human milk samples were collected from 8 subjects at specific timepoints during and after continuous intravenous ketamine infusion at 0.05 - 0.1 mg/kg/hr for 12 hours (NCT04037085). An UPLC-MS/MS assay methodology was successfully developed and validated for measuring ketamine, norketamine and dehydronorketamine concentrations in human milk samples. Noncompartmental analysis (NCA) and two-compartmental modeling was performed using WinNonlin for ketamine to estimate various maternal plasma pharmacokinetic parameters. Two compartmental behavior of ketamine was confirmed. To assess the infant drug exposure, the Milk to plasma ratio (M/P ratio) and % Relative Infant Dose (%RID) for ketamine were determined to be 3.64 and 0.0135% respectively. As % RID is < 10% threshold, low transfer of ketamine through human milk is expected. We conclude that it is safe to administer sub-anesthetic doses of short-term ketamine infusions in lactating women.


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Item Type: University of Pittsburgh ETD
Status: Unpublished
CreatorsEmailPitt UsernameORCID
Shahane, Aditi Dhananjayads212@pitt.eduads2120000-0003-1046-0345
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Committee ChairVenkataramanan, Ramanrv@pitt.edurv
Committee MemberLim,
Committee MemberShaik, Imamihs4@pitt.eduihs4
Date: 21 December 2022
Date Type: Publication
Defense Date: 2 December 2022
Approval Date: 21 December 2022
Submission Date: 13 December 2022
Access Restriction: 1 year -- Restrict access to University of Pittsburgh for a period of 1 year.
Number of Pages: 73
Institution: University of Pittsburgh
Schools and Programs: School of Pharmacy > Pharmaceutical Sciences
Degree: MS - Master of Science
Thesis Type: Master's Thesis
Refereed: Yes
Uncontrolled Keywords: Ketamine, Lactation, Pharmacokinetics, UPLC-MS/MS
Date Deposited: 21 Dec 2022 15:04
Last Modified: 21 Dec 2023 06:15


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