Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

Phase 3 Completed 98 enrolled Pacira Pharmaceuticals, Inc

RandomizedSequentialOpen-labelTreatment

Summary

Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries. Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.

Timeline

Start: 2019-04-02
Primary completion: 2019-08-30
Completion: 2019-09-24

Publications

Tirotta CF, de Armendi AJ, Horn ND, Hammer GB, Szczodry M, Matuszczak M, Wang NQ, Scranton R, Ballock RT. 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). J Clin Anesth. 2021 Dec;75:110503. doi: 10.1016/j.jclinane.2021.110503. Epub 2021 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bupivacaine	Other / unclassified	2 mg/kg	Other
Comparator	Bupivacaine	Other / unclassified	4 mg/kg	—

Indications

No indication recorded.