Safety and Efficacy of Fentanyl Citrate in Children
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically
ill children with mechanical ventilation
Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with
midazolam in children with mechanical ventilation.
Design: Double-blind randomized controlled study
Patients: Patients age 2 months through 18 years who are admitted in Seoul National
University Hospital pediatric intensive care unit, and applied with mechanical ventilation.
Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal saline)
is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents of the
patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing
pharmacist knows that.
Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent.
The start time of study is when the continuous infusion of midazolam and blind reagent are
begun. Assigned research nurse check Comfort behavior scale of the patient every hour
regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours
after begining. If there is any adverse effect or unexpected event, however, the study can be
early terminated.