Pacira Pharmaceuticals, Inc
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA).
This study will be conducted in 3 Parts (Part 1, Part 2, and Part 3) and a total of approximately 48 male and female subjects will be enrolled. Part 1 will enroll approximately 16 subjects, aged 2 to less than 6 years to obtain information on PK and safety. Subjects will be randomized 1:1 (8 EXPAREL subjects and 8 bupivacaine HCl subjects) to receive either a single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) or 0.25% bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) using LIA. The overall PK and safety profiles from Part 1 will be completed, an…
Inclusion Criteria: All of the following inclusion criteria must be met for eligibility: 1. Pediatric participants with congenital heart defects planned to undergo cardiac surgery with cardiopulmonary bypass 2. Male or female participants from 0 to less than 6 years of age on the day of surgery: 2 years to less than 6 years of age for Part 1; 6 months to less than 2 years of age for Part 2; 0 to less than 6 months of age for Part 3 3. American Society of Anesthesiologists (ASA) Classes 1 through 4. 4. Parent/guardian is able to speak, read, and understand the language of the ICF and provide…
A single dose of EXPAREL Injectable Product via LIA
A single dose of 0.25% bupivacaine via LIA