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Clinical Trials/ACTRN12611000087954
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Withdrawn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Withdrawn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.

Registry
who.int
Start Date
January 25, 2011
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Mike Shepherd

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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