Postoperative Pain
Conditions
Keywords
Analgesia, Cardiac Surgery, Pediatric
Brief summary
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).
Detailed description
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, analyzed, and reviewed to establish an appropriate study drug dose for Part 2. Subject enrollment for Part 2 will commence upon complete enrollment of Part 1, establishment of an appropriate study drug dose from the PK, and safety analysis of Part 1 and Data Safety Monitoring Board (DSMB) recommendations to proceed to Part 2. Part 2 will enroll approximately 16 subjects, aged 6 months to less than 2 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 or 0.25% bupivacaine HCl using LIA. The overall PK and safety profiles from Part 2 will be completed, analyzed, and reviewed to establish an appropriate study drug dose for Part 3. Subject enrollment for Part 3 will commence upon complete enrollment of Part 2, establishment of an appropriate study drug dose from the PK and safety analysis of Part 2, and DSMB recommendations to proceed to Part 3. Part 3 will enroll approximately 16 subjects aged 0 to less than 6 months 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 or 0.25% bupivacaine HCl using LIA.
Interventions
DRUGEXPAREL
A single dose of EXPAREL Injectable Product via LIA
DRUGbupivacaine
A single dose of 0.25% bupivacaine via LIA
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 6 Years
Healthy volunteers
No
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 informed consent for the participant. 5. Parent/guardian is able to adhere to the study visit schedule and complete all study assessments for the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The following model-predicted PK endpoint will be determined: | through 72 hours | • Area under the plasma concentration-versus-time curve (AUClast and AUC0-inf) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitals change from Baseline: | up to 4 postoperative days | temperature |
| Incidence of treatment-emergent adverse events (TEAEs) | 14 ± 3 days | — |
| Incidence of adverse events of special interest (AESIs) | 14 ± 3 days | — |
| Incidence of serious adverse events (SAEs) | 14 ± 3 days | — |
Countries
United States
Contacts
Primary ContactSarah Shaffer
Outcome results
None listed