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Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

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: Infant, Preterm

Intervention: low dose remifentanil (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Seoul National University Hospital


The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.

Clinical Details

Official title: Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant

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: Premature Infant Pain Profile

Secondary outcome: Adverse Reaction


Minimum age: N/A. Maximum age: 12 Weeks. Gender(s): Both.


Inclusion Criteria:

- preterm infants mechanically ventilated

- requiring peripherally induced central catheterization

- with informed consent of their parents

Exclusion Criteria:

- major congenital anomalies

- cardiopulmonary instability

- use of sedative, antiepileptic drugs or anesthetic drugs

- grade III or IV intraventricular hemorrhage

Locations and Contacts

Seoul National University Children's Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: December 2011
Last updated: September 11, 2013

Page last updated: August 23, 2015

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