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.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000087954

Enrollment

Registered

2011-01-25

Start date

2015-02-01

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

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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

3 Months to 2 Years

Healthy volunteers

Inclusion criteria

The study population will consist of children presenting to Starship CED who are 1/ Aged between three months and two years of age, and 2/ Require bladder catheterisation to obtain a diagnostic urine sample. A convenience sample will be enrolled that coincides with the presence of the research nurse. Children <3 months of age have not been included in this study as they are often provided with a dose of oral sucrose prior to any painful procedures. Children >2 years of age are not included as these children are usually able to provide a urine sample without catheterisation (Bray & Sanders, 2006).

Exclusion criteria

Altered level of consciousness Developmental delay Trapped gas scenarios (bowel obstruction, maxilla-facial injuries, and suspected pneumothorax) Acute respiratory conditions (asthma, bronchiolitis and pneumonia) Opiate or sedative medication administered within two hours

Outcome results