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Study to determine whether Remifentanil is effective for treating procedural pain in neonates

A randomised double-blind placebo-controlled trial of the efficacy of Remifentanil for procedural pain in neonates

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000385842
Acronym
Premi Remi
Enrollment
80
Registered
2012-04-04
Start date
2009-07-22
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 remifentanil infusion for alleviating pain in neonates requiring insertion of central venous lines for their medical care.

Interventions

Remifentanil syringes are loaded onto Braun infusion pumps and infused at 1 mL/kg/hour for 15 mins prior to commencement of the procedure. The neonate will recieve an intravenous infusion 0.1 mcg/kg/min remifentanil until central catheter has been threaded to its final position and secured OR until the central catheter has been threaded to its final position and all procedural activity has paused awaiting confirmation of catheter tip position by imaging (accepting that not all operators secure t

Remifentanil syringes are loaded onto Braun infusion pumps and infused at 1 mL/kg/hour for 15 mins prior to commencement of the procedure. The neonate will recieve an intravenous infusion 0.1 mcg/kg/min remifentanil until central catheter has been threaded to its final position and secured OR until the central catheter has been threaded to its final position and all procedural activity has paused awaiting confirmation of catheter tip position by imaging (accepting that not all operators secure the line at this time) at which time the infusion will be ceased.

Sponsors

Dr Susan M Lord
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
24 Weeks to 44 Weeks
Healthy volunteers
No

Inclusion criteria

Medically stable neonates Inpatient in JHCH NICU Level 3 Nursery Require insertion of a central venous catheter for their medical care 24–44 weeks corrected gestational age at the time of procedure

Exclusion criteria

Prior participation in this study (an infant can only participate once) Major congenital anomalies Severe hypoxic ischaemic encephalopathy Current clinical seizures Concomitant muscle relaxant Emergency central line insertions Lack of peripheral venous access for administration of study drug

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026