Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery

Recruiting Phase 1 Interventional Study
Postoperative Pain
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
0 – 6
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Pacira Pharmaceuticals, Inc · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
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…
Contacts

Sarah Shaffer

973-451-4071

sarah.shaffer@pacira.com

CONTACT