Phase 2 Completed N=14 Randomized Quadruple-blind Supportive Care

Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

Infant, Preterm

Source: ClinicalTrials.gov NCT01477892 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcomePrimary: Premature Infant Pain Profile — -0.60; 1.43 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Premature Infant Pain Profile	-0.60; 1.43	—
SECONDARY Adverse Reaction	3; 0; 1; 0; 0; 0	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01477892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.