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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
November 10, 2011
November 23, 2011
April 12, 2013
September 13, 2013
September 13, 2013
December 2011
April 2012   (Final data collection date for primary outcome measure)
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
Premature Infant Pain Profile [ Time Frame: first puncture of skin, after 15min of remifentanil infusion ]
Complete list of historical versions of study NCT01477892 on ClinicalTrials.gov Archive Site
Adverse Reaction [ Time Frame: during and after 10min of remifentanil continous infusion ]
bradycardia, hypotension, apnea, desaturation
Same as current
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Infant, Preterm
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
  • Experimental: low dose remifentanil
    continuous infusion of remifentanil 0.1mcg/kg/min
    Intervention: Drug: low dose remifentanil
  • Active Comparator: high dose remifentanil
    continuous infusion of remifentanil 0.25mcg/kg/min
    Intervention: Drug: low dose remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 12 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01477892
RFTN-01
11172_291 ( Other Identifier: Korea Food and Drug Administrator )
Yes
Not Provided
Not Provided
Han-Suk Kim, Seoul National University Hospital
Seoul National University Hospital
  • Ajou University School of Medicine
  • Severance Hospital
Not Provided
Seoul National University Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP