Status:
TERMINATED
Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Lead Sponsor:
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Conditions:
Cardiac Conditions
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the plasma concentration of bupivacaine at various time points after Exparel (bupivacaine liposome injectable suspension, Pacira Pharmaceuticals, Inc., Parsipp...
Detailed Description
To determine the pharmacokinetic profile and peak bupivacaine plasma concentration with the use of an Exparel/bupivacaine mixture in children ages two through seventeen (Cohort I). Cohort II covers ag...
Eligibility Criteria
Inclusion
- Every elective pediatric surgery patient ages two through seventeen years old, inclusive.
Exclusion
- Patients who fall outside of the age range for the study will be excluded. -Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. Any with Significant Liver Disease will also be excluded. Emergency patients will be excluded. Pregnant patients will be excluded.
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04685421
Start Date
July 15 2021
End Date
June 1 2023
Last Update
June 5 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nickalus Children's Hospital f/k/a Miami Children's Hospital
Miami, Florida, United States, 33155