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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: September 11, 2013
Last verified: September 2013
Results First Received: April 12, 2013  
Study Type: Interventional
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
Condition: Infant, Preterm
Intervention: Drug: low dose remifentanil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This noninferiority randomized, double-blind, controlled trial was conducted at the NICU of Seoul National University Children’s Hospital and Ajou University Hospital between November 2011 and April 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Dose Remifentanil

continuous infusion of remifentanil 0.25mcg/kg/min

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

Low Dose Remifentanil

continuous infusion of remifentanil 0.1mcg/kg/min

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


Participant Flow:   Overall Study
    High Dose Remifentanil     Low Dose Remifentanil  
STARTED     7     7  
COMPLETED     7     5  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Dose Remifentanil

continuous infusion of remifentanil 0.25mcg/kg/min

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

Low Dose Remifentanil

continuous infusion of remifentanil 0.1mcg/kg/min

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

Total Total of all reporting groups

Baseline Measures
    High Dose Remifentanil     Low Dose Remifentanil     Total  
Number of Participants  
[units: participants]
  7     5     12  
Age  
[units: participants]
     
<=18 years     7     5     12  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     3     3     6  
Male     4     2     6  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     7     5     12  
Gestatonal age  
[units: days]
Median ( Full Range )
  183  
  ( 171 to 214 )  
  181  
  ( 171 to 214 )  
  182  
  ( 171 to 223 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Adverse Reaction   [ Time Frame: during and after 10min of remifentanil continous infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
relatively small numbers of subjects


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pf. Han-suk Kim
Organization: Seoul National University Hospital
phone: +82-2-2072-0647
e-mail: kimhans@snu.ac.kr


No publications provided


Responsible Party: Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01477892     History of Changes
Other Study ID Numbers: RFTN-01, 11172_291
Study First Received: November 10, 2011
Results First Received: April 12, 2013
Last Updated: September 11, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board