Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2013-06-30
2015-01-31
Brief Summary
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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.
Detailed Description
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Adverse effect of fentanyl include hypotension, coma, and ileus. Unexpected event means the situation which study cannot last in, such as withdrawal of consent, necessity of drugs which can affect the level of consciousness of the patient, emergent interventional procedure, etc.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Fentanyl
midazolam and fentanyl citrate infusion
midazolam and fentanyl citrate infusion
comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
Control
midazolam and normal saline infusion
midazolam and normal saline infusion
comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
Interventions
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midazolam and fentanyl citrate infusion
comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
midazolam and normal saline infusion
comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age : from 2 months to 18 years
Exclusion Criteria
* children with drugs which can affect the level of consciousness
* children with renal disease
* children with hypotension (systolic blood pressure \< 70 + (2 x age in year) mmHg)
2 Months
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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June Dong Park, MD
Professor
Principal Investigators
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June Dong Park, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Lee B, Park JD, Choi YH, Han YJ, Suh DI. Efficacy and Safety of Fentanyl in Combination with Midazolam in Children on Mechanical Ventilation. J Korean Med Sci. 2019 Jan 7;34(3):e21. doi: 10.3346/jkms.2019.34.e21. eCollection 2019 Jan 21.
Other Identifiers
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MV_fentanyl
Identifier Type: -
Identifier Source: org_study_id