Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in healthy volunteers
Randomised, single-blind, placebo-controlled crossover study (n=12) assessing IV S(+)-ketamine PK/PD and experimental analgesia in healthy volunteers.
Details
S(+)-ketamine (Ketanest) intravenous infusion is studied to characterise pharmacokinetics and pharmacodynamics and to develop a PK/PD model predicting concentration and analgesic effect.
Primary aims are to obtain PK parameters of S(+)-ketamine and to assess its effects on experimental pain using electrical and heat pain models; outcomes include plasma concentration, analgesia, EEG, ECG and blood pressure.
Design: placebo-controlled, single-blind, randomised crossover with short IV infusions (≤100 minutes), arterial/venous sampling and standard safety monitoring; ondansetron available for nausea.