Health TrialsbyHealthPanel

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

ConditionDrug Effect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-17
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

supported on ECMO

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Pediatric Patients on ECMO Support4 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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