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Safety and Efficacy of Fentanyl Citrate

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Children

Intervention: midazolam and fentanyl citrate infusion (Drug); midazolam and normal saline infusion (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
June Dong Park, MD, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
June Dong Park, MD, Phone: 82-2-2072-3359, Email: jdparkmd@snu.ac.kr

Summary

Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically ill children with mechanical ventilation Purpose: To evaluate the safety and efficacy of fentanyl citrate in combination with midazolam in children with mechanical ventilation. Method: In the patient with mechanical ventilation in pediatric intensive care unit(2-18 year-of-age), compare the differences of level of sedation in the two group, one with only midazolam, and the other with midazolam and fentanyl.

Clinical Details

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

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

Primary outcome: improvement of Comfort B scale

Secondary outcome:

serious adverse effect

severe renal dysfunction

brain diseases

sedation failure

mortality

Eligibility

Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- children mechanically ventilated

- age : 2-18 years

Exclusion Criteria:

- children with neurologic disease

- children with renal disease

Locations and Contacts

June Dong Park, MD, Phone: 82-2-2072-3359, Email: jdparkmd@snu.ac.kr

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
June Done Park, MD, Phone: 82-2-2072-3359, Email: jdparkmd@snu.ac.kr
Additional Information

Starting date: June 2013
Last updated: June 22, 2014

Page last updated: August 23, 2015

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