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
Dr Susan M Lord
80 participants
Jul 22, 2009
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- Medically stable neonates
- Inpatient in JHCH NICU Level 3 Nursery
- Require insertion of a central venous catheter for their medical care
- –44 weeks corrected gestational age at the time of procedure
Exclusion Criteria7
- 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
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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 the line at this time) at which time the infusion will be ceased.
Locations(1)
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ACTRN12612000385842