Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

September 11, 2013 updated by: Han-Suk Kim, Seoul National University Hospital

Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose remifentanil
continuous infusion of remifentanil 0.1mcg/kg/min
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
Other Names:
  • high dose remifentanil
Active Comparator: high dose remifentanil
continuous infusion of remifentanil 0.25mcg/kg/min
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
Other Names:
  • high dose remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature Infant Pain Profile
Time Frame: first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Reaction
Time Frame: during and after 10min of remifentanil continous infusion
bradycardia, hypotension, apnea, desaturation
during and after 10min of remifentanil continous infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ajou University School of Medicine
Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 11, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFTN-01
  • 11172_291 (Other Identifier: Korea Food and Drug Administrator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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