Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

Seoul National University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infant, Preterm

Treatments: Drug: low dose remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01477892

RFTN-01

11172_291 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: Under 12 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

14 participants in 2 patient groups

low dose remifentanil

Experimental group

Description:

continuous infusion of remifentanil 0.1mcg/kg/min

Treatment:

Drug: low dose remifentanil

high dose remifentanil

Active Comparator group

Description:

continuous infusion of remifentanil 0.25mcg/kg/min

Treatment:

Drug: low dose remifentanil