Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

Infant, Preterm Clinical Trial

Official title:

Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477892
• Other study ID #: RFTN-01
• Secondary ID: 11172_291
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 10, 2011
• Last updated: September 11, 2013
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: September 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

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

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

Related Conditions & MeSH terms

• Infant, Preterm

Intervention

Drug:
• low dose remifentanil
non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ajou University School of Medicine, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature Infant Pain Profile	P0-P2 units on a scale; ; changes in PIPP from baseline (P0) to procedure (needle puncture, P2); PIPP (preterm infant pain profile); min 0 ~ max 21; higher pain scale on higher score	first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop	No
Secondary	Adverse Reaction	bradycardia, hypotension, apnea, desaturation	during and after 10min of remifentanil continous infusion	Yes