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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.
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.
Secondary ID [1] 253465 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural pain resulting from intermittant urinary catheterisation. 261019 0
Condition category
Condition code
Renal and Urogenital 259158 259158 0 0
Other renal and urogenital disorders
Anaesthesiology 259161 259161 0 0
Pain management

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257907 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 262007 0
The University of Wisconsin Children's Hospital (UWCH) pain scale will be used to evaluate procedural pain.
Timepoint [1] 262007 0
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.
Secondary outcome [1] 268937 0
Nil
Timepoint [1] 268937 0
Nil

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).
Minimum age
3 Months
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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)
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 3155 0
New Zealand
State/province [1] 3155 0

Funding & Sponsors
Funding source category [1] 258382 0
Charities/Societies/Foundations
Name [1] 258382 0
A+ Charitable Trust
Country [1] 258382 0
New Zealand
Primary sponsor type
Individual
Name
Mike Shepherd
Address
Children's Emergency Department, Auckland City Hospital, Park Road, Grafton, 1023, Auckland.
Country
New Zealand
Secondary sponsor category [1] 257526 0
Individual
Name [1] 257526 0
Kathryn Johnson
Address [1] 257526 0
Children's Emergency Department
Auckland City Hospital, Park Road, Grafton, 1023, Auckland.
Country [1] 257526 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260357 0
Northern Regional Ethics Committee
Ethics committee address [1] 260357 0
Ethics committee country [1] 260357 0
New Zealand
Date submitted for ethics approval [1] 260357 0
01/02/2011
Approval date [1] 260357 0
Ethics approval number [1] 260357 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32128 0
Dr Mike shepherd
Address 32128 0
Children's Emergency Department ADHB Private Bag 92024 Auckland Mail Centre Auckland 1142
Country 32128 0
New Zealand
Phone 32128 0
+64 9 3074902
Fax 32128 0
Email 32128 0
michaels@adhb.govt.nz
Contact person for public queries
Name 15375 0
Dr Mike Shepherd
Address 15375 0
Children's Emergency Department
ADHB
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 15375 0
New Zealand
Phone 15375 0
+64 9 307 4902
Fax 15375 0
Email 15375 0
michaels@adhb.govt.nz
Contact person for scientific queries
Name 6303 0
Dr Mike Shepherd
Address 6303 0
Children's Emergency Department
ADHB
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 6303 0
New Zealand
Phone 6303 0
+64 9 307 4902
Fax 6303 0
Email 6303 0
michaels@adhb.govt.nz

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.