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Remifentanil versus Fentanyl for pain control during elective endotracheal intubation in preterm neonates

Phase 2
Conditions
Respiratory distress syndrome of newborn.
Hyaline membrane disease
Registration Number
IRCT201310164113N7
Lead Sponsor
Vice Chancellor for Research of Tabriz University of of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
32
Inclusion Criteria

Preterm newborns with gestational age between 28 to 34 weeks and 6 days from last menstrual period of mother who was born in Alzahra teaching hospital of Tabriz; clinical criteria of respiratory distress (consists of: tachypnea, grunting, inter coastal retraction and increased oxygen requirement) and radio graphic findings of Respiratory Distress Syndrome; need for surfactant treatment by INSURE (Intubate, Surfactant, Extubate) procedure.
Exclusion criteria: other causes of respiratory distress in newborns; second or third degree AV heart block; use of fentanyl during 4 hours from delivery; severe asphyxia (APGAR score under 5 at 5th minutes after delivery ); impaired consciousness level; major congenital anomalies; difficult intubation due to facial anomalies; more than three attempts for intubation.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain Score. Timepoint: During endotracheal intubation. Method of measurement: PIPP-R pain assessment tool (Premature Infant Pain Profile-Revised).
Secondary Outcome Measures
NameTimeMethod
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