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RecruitingNCT03593408Updated Jan 9, 2026

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

An observational study in Drug Effect, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 0 Days to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Boston Children's Hospital · Observational

From the registry’s dates

  • Started Feb 2019; still recruiting 7 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
0 Days to 17 Years
Sex
All
01

Study summary

This study will measure plasma concentrations of dexmedetomidine, fentanyl, morphine and midazolam in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to understand the pharmacokinetics of these drugs in this setting.

02

Conditions studied

  • Drug Effect
03

In context

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All pediatric patients who present to Boston Children's Hospital (BCH) and supported on ECMO and receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of the sedation management.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-none

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pediatric Patients on ECMO Support

    Drug: Dexmedetomidine · Drug: Fentanyl · Drug: Midazolam · Drug: Morphine

Interventions

  • DrugDexmedetomidine

    Administered for sedation management per hospital protocol

  • DrugFentanyl

    Administered for sedation management per hospital protocol

  • DrugMidazolam

    Administered for sedation management per hospital protocol

  • DrugMorphine

    Administered for sedation management per hospital protocol

06

What researchers measure

Primary outcomes

  1. Change in plasma concentrations of dexmedetomidine

    Time frame: 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

  2. change in plasma concentrations of fentanyl

    Time frame: Throughout 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

  3. change in plasma concentrations of morphine

    Time frame: Throughout 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

  4. change in plasma concentrations of midazolam

    Time frame: Throughout 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

07

Study locations

1 of 1 sites recruiting
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
    • Viviane Nasr, MD · Contact
    • Viviane Nasr, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03593408
Lead sponsor
Boston Children's Hospital
Responsible party
Viviane Nasr (Cardiac Anesthesiologist, Boston Children's Hospital) — Principal investigator
First posted
Jul 20, 2018
Start date
Feb 8, 2019
Primary completion
Aug 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jan 9, 2026

Study contacts

Viviane Nasr, MD
Contact
viviane.nasr@childrens.harvard.edu
617-355-6225
Viviane Nasr, MD
principal investigator · Boston Children's Hospital

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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