What is it about?
This was a multicenter study pharmacokinetic and safety study on pediatric patients ages six too seventeen. The results demonstrated that the drug was safe in this population with pk bupivacaine levels well below the toxic threshold.
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Why is it important?
This study demonstrates the safety of liposomal bupivacaine in pediatric patients over ages six years and above.
Perspectives
Proving safety in this cohort resulted in the FDA issuing a pediatric indication for patients six and above. Further studies need to be done on still younger patients. Once the safety issue is removed, many efficacy studies can now be conducted.
Dr. Christopher F Tirotta
Nicklaus Children's Hospital
Read the Original
This page is a summary of: A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY), Journal of Clinical Anesthesia, December 2021, Elsevier,
DOI: 10.1016/j.jclinane.2021.110503.
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