ACTRN12611000087954
Withdrawn
Phase 4
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 Shepherd0 sites96 target enrollmentJanuary 25, 2011
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mike Shepherd
- Enrollment
- 96
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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