Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

This study has been completed.

Sponsor:

Collaborators:

Ajou University School of Medicine

Severance Hospital

Information provided by (Responsible Party):

Han-Suk Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01477892

First received: November 10, 2011

Last updated: July 20, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 10, 2011
Last Updated Date	July 20, 2012
Start Date ^ICMJE	December 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 22, 2011)	premature infant pain profile [ Time Frame: first puncture of skin, after 15min of remifentanil infusion ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01477892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 22, 2011)	adverse reaction [ Time Frame: during and after 10min of remifentanil continous infusion ] [ Designated as safety issue: Yes ] bradycardia, hypotension, apnea, desaturation
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population
Official Title ^ICMJE	Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Infant, Preterm
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	14
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	up to 12 Weeks
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01477892
Other Study ID Numbers ^ICMJE	RFTN-01, 11172_291
Has Data Monitoring Committee	Yes
Responsible Party	Han-Suk Kim, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Ajou University School of Medicine Severance Hospital
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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