Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old
Status:
Terminated
Trial end date:
2016-11-03
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label (all people involved know the identity of the
intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are
absorbed in the body, how are they distributed within the body and how are they removed from
the body over time) in children aged from birth to less than 2 years after a surgical
procedure that routinely produces moderate to severe acute post-surgical pain.
The trial will also evaluate the safety and tolerability of tapentadol oral solution in the
population studied and the effect of tapentadol oral solution on pain.