Not Yet RecruitingPhase 2ACTRN12612000386831

A study of intranasal remifentanil for intubation and surfactant administration in newborns

Intranasal remifentanil for pain management during intubation and surfactant administration in premature newborns – a randomised double blind controlled pilot study of efficacy


Sponsor

Associate Professor Ian Wright

Enrollment

40 participants

Start Date

Jul 1, 2012

Study Type

Interventional

Conditions

Summary

The primary purpose of this study is to determine the efficacy of intranasal remifentanil for improving intubating conditions in neonates requiring the INSURE procedure as part of their medical care. Usual pain management (comfort/environmental measures and age/weight-appropriate sucrose) will be provided to all neonates.


Eligibility

Sex: Both males and femalesMin Age: 28 WeekssMax Age: 44 Weekss

Inclusion Criteria3

  • Born at John Hunter Childrens Hospital and transferred to Neonatal Intensive Care Unit.
  • Require the INSURE procedure as part of their medical care.
  • Are 28–44 weeks post-conceptional age at the time of the procedure.

Exclusion Criteria5

  • Need for urgent intubation for resuscitation.
  • Major congenital anomalies likely to influence reliability of the primary outcome measure.
  • Severe neurological obtundation.
  • Current clinical seizures.
  • Concomitant muscle relaxant.

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Interventions

Prior to the intubation surfactant extubation (INSURE) procedure, babies will receive standard care plus intranasal remifentanil 2 micrograms/kg.

Prior to the intubation surfactant extubation (INSURE) procedure, babies will receive standard care plus intranasal remifentanil 2 micrograms/kg.


Locations(1)

Australia

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ACTRN12612000386831