Safety and Efficacy of Fentanyl Citrate in Children

November 23, 2015 updated by: June Dong Park, MD, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fentanyl
midazolam and fentanyl citrate infusion
Drug: midazolam 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
Other Names:
  • midazolam injection
  • fentanyl citrate injection
Placebo Comparator: Control
midazolam and normal saline infusion
Drug: midazolam 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
Other Names:
  • midazolam injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
from the start of fentanyl/placebo infusion to 48 hours after start of infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effect
Time Frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion

category of adverse effects

  1. hypotension
  2. coma
  3. ileus
from the start of fentanyl/placebo infusion to 48 hour after start of infusion
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
from the start of fentanyl/placebo infusion to 48 hour after start of infusion
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.
from the start of fentanyl/placebo infusion to 48 hour after start of infusion
mortality
Time Frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
in-hospital death
from the start of fentanyl/placebo infusion to 48 hour after start of infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: June Dong Park, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

June 22, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV_fentanyl

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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