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Trial registered on ANZCTR
Registration number
ACTRN12611000087954
Ethics application status
Not yet submitted
Date submitted
22/01/2011
Date registered
25/01/2011
Date last updated
29/06/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Randomised controlled trial of continuous flow inhaled nitrous oxide as analgesia for infant urinary catheterisation.
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Scientific title
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.
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Secondary ID [1]
253465
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Procedural pain resulting from intermittant urinary catheterisation.
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Condition category
Condition code
Renal and Urogenital
259158
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0
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Other renal and urogenital disorders
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Anaesthesiology
259161
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
257907
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Treatment: Drugs
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Comparator / control treatment
Current standard of care is no analgesia or sedation for this procedure.
Children will be distracted and reassured by caregiver in standard manner
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Control group
Active
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Outcomes
Primary outcome [1]
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The University of Wisconsin Children's Hospital (UWCH) pain scale will be used to evaluate procedural pain.
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Assessment method [1]
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Timepoint [1]
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A pain score will be determined from video footage by blinded observer, one minute before the N2O delivery starts, just before the procedure starts and when the catheter has been inserted.
Blinding will be achieved by using nurses who have not been involved in any of the procedures to assess the pain scores from edited video footage. In order to blind these pain score observers both controls and treatment arm participants will have the nitrous blender and scavenger running (creating the same background noise) and will have a mask and circuit on the bed. The videos provided to the pain assessors will be edited to only include the relevant pain assessment periods (prior to mask application, immediately prior to procedure starting the procedure and after catheter insertion). The treatment group will have the mask removed from their face for approximately 5 seconds during the assessment periods noted above.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key 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).
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Minimum age
3
Months
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Maximum age
2
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study population will consist of children presenting to Starship CED who are aged between three months and two years of age, and require bladder catheterisation to obtain a diagnostic urine sample. A convenience sample will be enrolled that coincides with the presence of the research nurse. The study will be explained to the caregivers of patients meeting the inclusion criteria and informed consent sought. After consent is gained children will then be randomly allocated to the control or intervention group by envelope containing a 1:1 ratio of allocation into each group (see below)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One hundred and ten sequentially numbered opaque sealed envelopes will be placed in the CED pharmacy room, which has key pad access only. Study numbers will be assigned sequentially, and randomization will be achieved by generating numerical codes in random permuted blocks. Each envelope will contain the words Nitrous Oxide or Control (with a 50% probability of each).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Nil
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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Date of first participant enrolment
Anticipated
1/02/2015
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
96
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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A+ Charitable Trust
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Address [1]
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Research Office, Room 142.004, Level 14, Bldg 1, Auckland City Hospital, Park Road, Grafton, 1023, Auckland.
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Mike Shepherd
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Address
Children's Emergency Department, Auckland City Hospital, Park Road, Grafton, 1023, Auckland.
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Country
New Zealand
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Secondary sponsor category [1]
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Individual
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Name [1]
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Kathryn Johnson
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Address [1]
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Children's Emergency Department
Auckland City Hospital, Park Road, Grafton, 1023, Auckland.
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Country [1]
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Northern Regional Ethics Committee
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Ethics committee address [1]
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Private Bag 92-522, Wellesley St
Auckland, 1061
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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01/02/2011
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Approval date [1]
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Ethics approval number [1]
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Summary
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.
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Trial website
Nil
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Mike shepherd
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Address
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Children's Emergency Department ADHB Private Bag 92024 Auckland Mail Centre Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 3074902
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr Mike Shepherd
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Address
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Children's Emergency Department
ADHB
Private Bag 92024
Auckland Mail Centre
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 307 4902
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr Mike Shepherd
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Address
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Children's Emergency Department
ADHB
Private Bag 92024
Auckland Mail Centre
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 307 4902
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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