Clinical trial NCT02172014: Safety and Efficacy of Fentanyl Citrate in Children
Official title: Safety and Efficacy of Fentanyl Citrate in Combination With Midazolam in Critically Ill Children With Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Children
Keywords: Mechanical Ventilation
Sedation
Fentanyl
Midazolam
Comfort behavior scale
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: difference between measured Comfort behavior scale and target Comfort behavior scale
timeFrame: from the start of fentanyl/placebo infusion to 48 hours after start of infusion
Secondary outcomes:
measure: adverse effect
timeFrame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
measure: renal dysfunction
timeFrame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
measure: sedation failure
timeFrame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
measure: mortality
timeFrame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: June Dong Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.