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NCT Number: NCT03593408

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

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.

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Key information

Conditions

Drug Effect

Age range

0 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Viviane Nasr, MD

CONTACT

Viviane Nasr, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Administered for sedation management per hospital protocol

Fentanyl

Drug

Administered for sedation management per hospital protocol

midazolam

Drug

Administered for sedation management per hospital protocol

Morphine

Drug

Administered for sedation management per hospital protocol

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

Study contacts

Contact information is provided by the study sponsor or research team.

Viviane Nasr, MD

CONTACT

[email protected]

617-355-6225

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2018
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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