Randomised controlled trial of continuous flow inhaled nitrous oxide as analgesia for infant urinary catheterisation.
Randomised controlled trial of children between the age of 3 months and 2 years requiring urinary catheterisation, comparing continuous flow inhaled nitrous oxide with placebo for the provision of procedural analgesia.
Mike Shepherd
96 participants
Feb 1, 2015
Interventional
Conditions
Summary
This study explores the use of a continuous-flow nitrous oxide system to alleviate the pain and anxiety young children experience with a commonly performed procedure in a paediatric emergency department. The study will look specifically at the use of nitrous oxide in children older than 3 months and younger than 2 years of age who require bladder catheterisation for the purposes of obtaining a diagnostic urine sample. Bladder catheterisation is known to be painful and distressing and currently we do not have a method of reducing this pain and distress in children of this age. The study will be conducted in the Children’s Emergency Department (CED) at Starship Children’s hospital. Children will be randomised to either receive standard treatment (no analgesia or procedural sedation) or nitrous oxide. We will measure how much distress each child experiences and how much sedation is achieved during the procedure using standardised scoring systems. Children will also be monitored carefully to ensure they remain safe during the procedure. We will then be able to determine whether the nitrous oxide is effective at reducing pain and distress for these types of procedure. We hope this will allow us to develop a better way of caring for young children undergoing other painful and distressing procedures in the Emergency Department. We also hope this information will be useful to other emergency departments and providers in other settings where young children have procedures.
Eligibility
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Interventions
Inhalation of continuous flow nitrous oxide using blender and scavenger for the provision of procedural analgesia. Flow will be 5l/min, 70% nitrous oxide in oxygen, for minimum of 3 minutes prior to procedure and ceased after catheter is removed. The procedure will be bladder catheterisation for the purpose of diagnostic urine collection. The total procedure duration is approximately 5 minutes.
Locations(1)
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ACTRN12611000087954