Understanding Sedative and Pain Medication Levels in Children on ECMO

This study is looking at how the body processes common sedatives and pain medications like dexmedetomidine, fentanyl, and morphine in children (ages newborn to 17 years old) who are on ECMO (Extracorporeal Membrane Oxygenation). ECMO is a life support system that helps the heart and lungs. Researchers want to measure the levels of these drugs in the blood over time to better understand how they work in children on ECMO. This information can help doctors give the right doses to keep children comfortable and safe. The study aims to enroll 20 participants and is currently observational, meaning it watches what happens without giving new treatments. The study's status is currently unclear.

Study design
This is an observational study involving up to 20 participants, looking at how the body processes certain medications.
What's involved
Participants will have blood samples taken at specific times (baseline, 30, 60, 120 minutes, 4, 6, 12 hours after changes in medication, and after the medication is stopped) to measure drug levels.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed throughout the duration of their sedation management with the study drugs, and for up to 4 hours after the drug is stopped.

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NCT03593408

Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support

Recruiting
Not specifiedAges 0–17Observational
Boston Children's Hospital
~20 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:DexmedetomidineFentanylMidazolamMorphine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in plasma concentrations of dexmedetomidine
Measured over Throughout the duration of sedation management with dexmedetomidine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
+3 more outcomes measured
Drug Effect

NCT03593408

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Viviane Nasr, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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Eligibility criteria

Inclusion

supported on ECMO
receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management

Exclusion

none
  • Change in plasma concentrations of dexmedetomidineThroughout the duration of sedation management with dexmedetomidine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
  • change in plasma concentrations of fentanylThroughout the duration of sedation management with fentanyl at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
  • change in plasma concentrations of morphineThroughout the duration of sedation management with morphine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
  • change in plasma concentrations of midazolamThroughout the duration of sedation management with midazolam at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped