RecruitingPhase 2ACTRN12612000385842

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


Sponsor

Dr Susan M Lord

Enrollment

80 participants

Start Date

Jul 22, 2009

Study Type

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

Sex: Both males and femalesMin Age: 24 WeekssMax Age: 44 Weekss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a pain relief medication called remifentanil, given as a continuous drip, can reduce pain in premature and newborn babies who need a central venous line (a small tube placed into a large vein) inserted as part of their medical care. Pain from this procedure in newborns is a serious concern. Researchers will compare pain scores in babies who receive remifentanil versus those who do not. You may be eligible if: - Your baby is medically stable - Your baby is currently an inpatient in the NICU at John Hunter Children's Hospital - Your baby needs a central venous catheter placed for their medical care - Your baby is between 24 and 44 weeks corrected gestational age at the time of the procedure You may NOT be eligible if: - Your baby has previously taken part in this study - Your baby has major congenital anomalies - Your baby has severe hypoxic ischaemic encephalopathy (brain injury from lack of oxygen) - Your baby is having active clinical seizures - Your baby is currently on a muscle relaxant medication - The central line insertion is an emergency procedure - Your baby does not have peripheral venous access for the study drug Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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/m

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)

Australia

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ACTRN12612000385842