Actively Recruiting
Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
Led by Boston Children's Hospital · Updated on 2026-01-09
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how sedative and pain-relief drugs behave in the blood of pediatric patients supported with extracorporeal membrane oxygenation (ECMO). The focus is on understanding the concentrations of dexmedetomidine, fentanyl, morphine, and midazolam in this specialized setting. This observational study aims to improve knowledge about these drugs' pharmacokinetics during ECMO support in children. The study observes pediatric patients who are receiving one or a combination of dexmedetomidine, fentanyl, midazolam, or morphine as part of their sedation management. These drugs are administered according to hospital protocols while the patients are on ECMO support. There are no intervention assignments because this is an observational study without experimental treatments. Participants are monitored through blood samples taken at multiple time points, including baseline and various intervals after drug bolus or infusion changes, and after stopping the drugs. Researchers measure the changes in plasma drug concentrations over time to understand how the medications behave during sedation management on ECMO. The study is led by Boston Children's Hospital and includes children from birth up to 17 years old.
CONDITIONS
Brief Title
Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Supported on extracorporeal membrane oxygenation (ECMO)
- Receiving one or a combination of dexmedetomidine, fentanyl, midazolam, or morphine for sedation management
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Duration of sedation management with sedatives
Participants who are supported on ECMO and receiving sedatives are observed for pharmacokinetic changes in drug plasma concentrations.
Multiple blood sampling visits at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or infusion change, plus additional assessments up to 4 hours after drug cessation
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
V
Viviane Nasr, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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