Safety and Efficacy of Fentanyl Citrate in Children

Seoul National University

Status and phase

Completed

Phase 2

Conditions

Children

Treatments

Drug: midazolam and fentanyl citrate infusion

Drug: midazolam and normal saline infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT02172014

MV_fentanyl

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

2 months to 18 years old

Volunteers

No Healthy Volunteers

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)