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Local Anesthetic

Bupivacaine liposome for Cardiac Conditions (CohortI-II Trial)

Phase 1
Waitlist Available
Led By Christopher F Tirotta, MD
Research Sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 hours
Awards & highlights

CohortI-II Trial Summary

This trial will test a new pain medication to see how well it works for kids who just had heart surgery.

Eligible Conditions
  • Cardiac Conditions

CohortI-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bupivacaine

CohortI-II Trial Design

1Treatment groups
Experimental Treatment
Group I: Liposomal Bupivacaine PKExperimental Treatment1 Intervention
Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine liposome
2016
Completed Phase 4
~420

Find a Location

Who is running the clinical trial?

Nicklaus Children's Hospital f/k/a Miami Children's HospitalLead Sponsor
24 Previous Clinical Trials
872,958 Total Patients Enrolled
Christopher F Tirotta, MDPrincipal InvestigatorNicklaus Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what demographic is enrollment in this experiment restricted?

"This research requires 30 volunteer participants aged between two and seventeen who have a cardiac disorder. In addition, all entrants must meet the following criteria: All elective pediatric surgical patients ranging from two to seventeen years of age inclusive."

Answered by AI

Are there any age restrictions for enrolment in this experiment?

"The qualifications for inclusion in this study demand that participants are between the age of 2 and 17. Currently, there exists 23 clinical trials tailored to minors and 170 studies for those over 65 years old."

Answered by AI

Are there any openings for this medical trial at the present time?

"Affirmative. Clinicaltrials.gov logs indicate that this medical research project, which was initially posted on July 15th 2021 is actively seeking patients to join their study. 30 individuals need to be enrolled from 1 clinical site."

Answered by AI

What ailments have been effectively alleviated with Bupivacaine liposome?

"Bupivacaine liposome is an applicable treatment for permphigus, acute nonspecific tenosynovitis and general anesthesia."

Answered by AI

To what extent could Bupivacaine liposome be deleterious to patients?

"Due to the limited data collected in this Phase 1 trial, our team at Power gave Bupivacaine liposome a score of one for safety standards."

Answered by AI

Has there previously been research conducted related to Bupivacaine liposome?

"Currently, research is being conducted on Bupivacaine liposome in 109 trials with 18 of them having reached Phase 3. Of those studies taking place in the USA, the majority are situated around Philadelphia; nonetheless, there are a total of 144 sites offering this treatment."

Answered by AI

What is the size of this experiment's participant pool?

"Affirmative, the information on clinicaltrials.gov suggests that this trial is actively enrolling patients. It was initially published on July 15th 2021 and has since been updated as recently as April 4th 2022. 30 individuals are in need of recruitment at 1 medical centre."

Answered by AI
Recent research and studies
~4 spots leftby Apr 2025