RecruitingPhase 1NCT06271265

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

A Multicenter, Open-label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 Years Undergoing Cardiac Surgery

Sponsor

Pacira Pharmaceuticals, Inc

Enrollment

48 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain

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).

Eligibility

Min Age: 0 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called EXPAREL and a drug called bupivacaine for people with postoperative pain. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 0 Years to 6 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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