Safety and Efficacy of Fentanyl Citrate in Children

Phase 2

Completed

Interventions: Drug: midazolam and fentanyl citrate infusion
Drug: midazolam and normal saline infusion

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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Fentanyl	midazolam and fentanyl citrate infusion	midazolam and fentanyl citrate infusion
Control	midazolam and normal saline infusion	midazolam and normal saline infusion

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (1): Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of

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