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Trial registered on ANZCTR


Trial ID
ACTRN12612000385842
Ethics application status
Approved
Date submitted
2/04/2012
Date registered
4/04/2012
Date last updated
5/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to determine whether Remifentanil is effective for treating procedural pain in neonates
Scientific title
A randomised double-blind placebo-controlled trial of the efficacy of Remifentanil for procedural pain in neonates
Secondary ID [1] 280262 0
Nil
Universal Trial Number (UTN)
Trial acronym
Premi Remi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief for neonates undergoing insertion of a central venous catheter 286210 0
Condition category
Condition code
Reproductive Health and Childbirth 286421 286421 0 0
Complications of newborn
Anaesthesiology 286437 286437 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284609 0
Treatment: Drugs
Comparator / control treatment
The control treatment is a placebo of plain 5% Dextrose syringes, which are loaded onto Braun infusion pumps and infused at 1 mL/kg/hour for 15 mins prior to commencement of the procedure and until the 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.
Control group
Placebo

Outcomes
Primary outcome [1] 286867 0
The primary outcome is to determine the efficacy of remifentanil infusion for alleviating pain in neonates requiring insertion of central venous lines for their medical care, using pain scores (PIPPS) and facial grimacing derived from clinical monitoring data and facial coding data
Timepoint [1] 286867 0
Baseline (T0), during skin preparation (T1), during needle insertion (T2), and during recovery (T3).
Secondary outcome [1] 296842 0
To collect steady-state pharmacokinetic data for analgesic infusions of remifentanil in neonates of varying gestational maturity.
Timepoint [1] 296842 0
Once during procedure.

Eligibility
Key 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
Minimum age
24 Weeks
Maximum age
44 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by randomisation by computer and the allocation schedule held only by the trial/manufacturing pharmacist so that NICU staff members are blinded to the nature of the solution.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285020 0
Hospital
Name [1] 285020 0
John Hunter Hospital Charitable Trust Fund
Address [1] 285020 0
Lookout Rd
New Lambton NSW 2310
Country [1] 285020 0
Australia
Funding source category [2] 285027 0
Charities/Societies/Foundations
Name [2] 285027 0
Australian and New Zealand College of Anaesthetists
Address [2] 285027 0
ANZCA House
630 St Kilda Road
Melbourne Vic 3004
Country [2] 285027 0
Australia
Primary sponsor type
Individual
Name
Dr Susan M Lord
Address
Anaesthesia, Intensive Care & Pain Management
John Hunter Children’s Hospital
Lookout Road
New Lambton
New South Wales 2310
Country
Australia
Secondary sponsor category [1] 283886 0
Individual
Name [1] 283886 0
Associate Professor Ian Wright
Address [1] 283886 0
Neonatal Intensive Care Unit
John Hunter Children's Hospital
Lookout Road
New Lambton
New South Wales 2310
Country [1] 283886 0
Australia
Other collaborator category [1] 260682 0
Individual
Name [1] 260682 0
Kate O'Hara
Address [1] 260682 0
Hunter Medical Research Institute
John Hunter Hospital
Lookout Road
New Lambton
New South Wales 2310
Country [1] 260682 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287024 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 287024 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 287024 0
Australia
Date submitted for ethics approval [1] 287024 0
Approval date [1] 287024 0
25/11/2008
Ethics approval number [1] 287024 0
08/08/20/3.08

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34009 0
Address 34009 0
Country 34009 0
Phone 34009 0
Fax 34009 0
Email 34009 0
Contact person for public queries
Name 17256 0
Associate Professor Ian Wright
Address 17256 0
Neonatal Intensive Care Unit
Level 3
John Hunter Children’s Hospital
Lookout Rd
New Lambton Heights
NSW 2310
Country 17256 0
Australia
Phone 17256 0
+61 2 49214362
Fax 17256 0
Email 17256 0
Ian.Wright@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 8184 0
Associate Professor Ian Wright
Address 8184 0
Neonatal Intensive Care Unit
Level 3
John Hunter Children’s Hospital
Lookout Rd
New Lambton Heights
NSW 2310
Country 8184 0
Australia
Phone 8184 0
+61 2 49214362
Fax 8184 0
Email 8184 0
Ian.Wright@hnehealth.nsw.gov.au