Safety and Efficacy of Fentanyl Citrate in Children

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172014
• Other study ID #: MV_fentanyl
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2013
• Last updated: November 23, 2015
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Children

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	adverse effect	category of adverse effects; hypotension; coma; ileus	from the start of fentanyl/placebo infusion to 48 hour after start of infusion	Yes
Secondary	renal dysfunction	estimate GFR (Schwartz equation) < 50 mL/minute/1.73m2	from the start of fentanyl/placebo infusion to 48 hour after start of infusion	No
Secondary	sedation failure	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	No
Secondary	mortality	in-hospital death	from the start of fentanyl/placebo infusion to 48 hour after start of infusion	No