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Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477892
First Posted: November 23, 2011
Last Update Posted: September 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ajou University School of Medicine
Severance Hospital
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
  Purpose
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.

Condition Intervention Phase
Infant, Preterm Drug: low dose remifentanil Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant

Resource links provided by NLM:


Further study details as provided by Han-Suk Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Adverse Reaction [ Time Frame: during and after 10min of remifentanil continous infusion ]
    bradycardia, hypotension, apnea, desaturation


Enrollment: 14
Study Start Date: December 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: high dose remifentanil

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477892


Locations
Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Ajou University School of Medicine
Severance Hospital
  More Information

Responsible Party: Han-Suk Kim, Assist Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01477892     History of Changes
Other Study ID Numbers: RFTN-01
11172_291 ( Other Identifier: Korea Food and Drug Administrator )
First Submitted: November 10, 2011
First Posted: November 23, 2011
Results First Submitted: April 12, 2013
Results First Posted: September 13, 2013
Last Update Posted: September 13, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics