Ropivacaine has a favourable toxicity profile for epidural anaesthesia in a
dults, so it may also be an appropriate agent for epidural analgesia in chi
ldren. We therefore designed this study to determine the pharmacokinetic va
riables of ropivacaine relevant to the risk of toxicity, after caudal admin
istration in children. We studied nine healthy children, aged 1-6 years who
received 1 ml.kg(-1) of ropivacaine 0.25% for caudal analgesia. Venous blo
od samples were collected at intervals for 12 h after injection. Total plas
ma concentration of ropivacaine was assayed by high performance liquid chro
matography, and pharmacokinetic descriptors were estimated from the plasma
concentration-time data. The median peak venous plasma concentration was 79
9 mu g.l(-1) [interquartile range (IQR) 707-1044 mu g.l(-1)], and was reach
ed at a median time of 1.5 h (IQR 0.5-2 h). The mean elimination half-life
was 3.9 h (95% CI 2.7-5.0 h), and the mean apparent clearance and volume of
distribution were 7.6 +/- 1.6 ml.min(-1).kg(-1) (95% CI 6.1-9.1 ml.min(-1)
.kg(-1)) and 2.4 +/- 0.6 l.kg(-1) (95% CI 1.9-3.0 l.kg(-1)), respectively.
Analgesia was satisfactory in all cases and no systemic ropivacaine toxicit
y was observed. Caudal administration of weight-adjusted doses of ropivacai
ne to children resulted in systemic exposure similar to that reported for a
dults. No systemic toxicity was observed. The findings strengthen predictio
ns that the relative systemic safety of epidural ropivacaine in adults will
apply to children. However, the pharmacokinetics and safety of epidural ro
pivacaine need to be studied further in children with circumstances that af
fect drug disposition and systemic tolerance.