Recruiting

Sedatives & Analgesics

Sponsor:

Boston Children's Hospital

Code:

NCT03593408

Conditions

Drug Effect

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine

Fentanyl

Midazolam

Morphine

Study Details

Brief 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.

Conditions

Drug Effect

Study ID

NCT03593408

Start date

Feb 8, 2019

Status verified date

Jan, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric Patients on ECMO Support

Interventions

Dexmedetomidine

Administered for sedation management per hospital protocol

Fentanyl

Administered for sedation management per hospital protocol

Midazolam

Administered for sedation management per hospital protocol

Morphine

Administered for sedation management per hospital protocol

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Viviane Nasr, MD

617-355-6225viviane.nasr@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Viviane Nasr, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-01-09.