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

January 8, 2026 updated by: Viviane Nasr, Boston Children's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
          • Viviane Nasr, MD
        • Principal Investigator:
          • Viviane Nasr, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 17 years (Child)

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.

Description

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:

-none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric Patients on ECMO Support
Drug: Dexmedetomidine
Administered for sedation management per hospital protocol
Drug: Fentanyl
Administered for sedation management per hospital protocol
Drug: Midazolam
Administered for sedation management per hospital protocol
Drug: Morphine
Administered for sedation management per hospital protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Viviane Nasr, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2019

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Estimated)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00028380

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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