Safety and Efficacy of Fentanyl Citrate in Children

NCT02172014 | Completed Phase 2 DMC

• 1 other identifier: MV_fentanyl
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Children

Keywords

Mechanical Ventilation; Sedation; Fentanyl; Midazolam; Comfort behavior scale

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• adverse effect

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

• renal dysfunction

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

• sedation failure

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

• mortality

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

Study Arms (2)

Fentanyl

EXPERIMENTAL

midazolam and fentanyl citrate infusion

Drug: midazolam and fentanyl citrate infusion

Control

PLACEBO COMPARATOR

midazolam and normal saline infusion

Drug: midazolam and normal saline infusion

Interventions

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

Also known as: midazolam injection, fentanyl citrate injection

Fentanyl

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

Also known as: midazolam injection

Control

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children mechanically ventilated
• age : from 2 months to 18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30662387 DERIVED

MeSH Terms

Interventions

Midazolam; Fentanyl

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• June Dong Park, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: June 24, 2014
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

KR (1)