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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000386831

Acronym

RHINO

Enrollment

Registered

2012-04-04

Start date

2012-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

28 Weeks to 44 Weeks

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results