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
Summary
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
Eligibility
Minimum age: N/A.
Maximum age: 12 Weeks.
Gender(s): Both.
Criteria:
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
|
