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Completed

NCT Number: NCT01477892

Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

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.

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Key information

Conditions

Infant, Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Children's Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose remifentanil

Drug

non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control

Other names: high dose remifentanil

Primary outcomes

  1. 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 outcomes

  1. Adverse Reaction

    Time frame: during and after 10min of remifentanil continous infusion

    bradycardia, hypotension, apnea, desaturation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ajou University School of Medicine
  • Severance Hospital

Registry information

Official study title

Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 23, 2011
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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