Children
Conditions
Keywords
Mechanical Ventilation, Sedation, Fentanyl, Midazolam, Comfort behavior scale
Brief 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.
Detailed description
Comfort behavior scale consists of 7 components of alertness, calmness, respiratory response, crying, physical movement, muscle tone, and facial tension. Because intubated patients cannot be evaluated 'crying', however, we use 6 components among total of all 7 components, except 'crying'. 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.
Interventions
DRUGmidazolam 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
DRUGmidazolam 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
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* children mechanically ventilated * age : from 2 months to 18 years
Exclusion criteria
* children with neurologic disease * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| difference between measured Comfort behavior scale and target Comfort behavior scale | from the start of fentanyl/placebo infusion to 48 hours after start of infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse effect | from the start of fentanyl/placebo infusion to 48 hour after start of infusion | category of adverse effects 1. hypotension 2. coma 3. ileus |
| renal dysfunction | from the start of fentanyl/placebo infusion to 48 hour after start of infusion | estimate GFR (Schwartz equation) \< 50 mL/minute/1.73m2 |
| sedation failure | from the start of fentanyl/placebo infusion to 48 hour after start of infusion | the case that can't reach target level of sedation, even though use of maximal infusion rate of midazolam and blind reagent. |
| mortality | from the start of fentanyl/placebo infusion to 48 hour after start of infusion | in-hospital death |
Countries
South Korea
Outcome results
None listed