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Completed

NCT Number: NCT02172014

Safety and Efficacy of Fentanyl Citrate in Children

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.

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Key information

Conditions

Children

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

midazolam and fentanyl citrate infusion

Drug

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 names: midazolam injection, fentanyl citrate injection

midazolam and normal saline infusion

Drug

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 names: midazolam injection

Primary outcomes

  1. difference between measured Comfort behavior scale and target Comfort behavior scale

    Time frame: from the start of fentanyl/placebo infusion to 48 hours after start of infusion

Secondary outcomes

  1. adverse effect

    Time frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion

    category of adverse effects

    • hypotension
    • coma
    • ileus

  2. renal dysfunction

    Time frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion

    estimate GFR (Schwartz equation) < 50 mL/minute/1.73m2

  3. sedation failure

    Time frame: 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.

  4. mortality

    Time frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion

    in-hospital death

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Safety and Efficacy of Fentanyl Citrate in Combination With Midazolam in Critically Ill Children With Mechanical Ventilation

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2014
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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