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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   up to 12 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 27, 2014