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Trial registered on ANZCTR
Registration number
ACTRN12619000612112
Ethics application status
Approved
Date submitted
10/04/2019
Date registered
24/04/2019
Date last updated
21/04/2024
Date data sharing statement initially provided
24/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
One-Needle Approach to Paediatric Procedural Sedation using Ketamine: A Randomised Control Trial.
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Scientific title
One-Needle Approach to Paediatric Procedural Sedation using Ketamine: A Randomised Control Trial.
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Secondary ID [1]
297938
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Nil
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Universal Trial Number (UTN)
U1111-1231-5033
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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 Sedation
312327
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Condition category
Condition code
Emergency medicine
310892
310892
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0
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Other emergency care
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Anaesthesiology
311019
311019
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study has two intervention arms, one arm will receive 3mg/kg via intramuscular injection and the other arm will receive 4mg/mg via intramuscular injection. Participants will be randomised in a 1:1:1 ratio between the two intervention arms and control. Intramuscular injections will be administered by the treating doctor or nurse. Where adequate sedation to undertake the required procedure is not achieved with the initial intramuscular dose, additional intramuscular or intravenous doses of ketamine will be administered at treating clinician discretion.
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Intervention code [1]
314161
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Treatment: Drugs
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Comparator / control treatment
The control group will receive procedural sedation using intravenous ketamine with an initial dose of 1mg/kg and additional doses titrated to effect at clinician discretion
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome of this study is proportion of children who achieve adequate procedural sedation to allow completion of the required procedure with a single needle for the child.
Adequacy of procedural sedation will be measured using the University of Michigan Sedation Scale (UMSS). A score or 3 or greater will be considered adequate procedural sedation.
To reduce bias at least 2 staff will complete the rating of the sedation and will include 2 or more of: the clinician responsible for managing the sedation; the clinician responsible for performing the procedure; and the nurse involved in the procedure.
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Assessment method [1]
319714
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Timepoint [1]
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At the completion of the procedure.
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Secondary outcome [1]
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Emergency Department length of stay measured from time of arrival to the emergency department to time of departure from the emergency department recorded in the hospital patient management system.
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Assessment method [1]
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Timepoint [1]
369266
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Discharge from emergency department
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Secondary outcome [2]
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Length of time in emergency department requiring 1:1 nursing care has recorded by nursing staff on patient observation sheets and study case report forms (CRF).
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Assessment method [2]
369267
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Timepoint [2]
369267
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Time of change to standard level nursing care
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Secondary outcome [3]
369268
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Length of stay from time of randomisation as measured from the time of randomisation recorded on the electronic randomisation platform and discharge from the emergency department recorded in the hospital patient management system.
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Assessment method [3]
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Timepoint [3]
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Time of discharge from the emergency department
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Secondary outcome [4]
369269
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Number of needles for patient during the administration of the sedation. For the intravenous arm this will be reported as the number of attempts to achieve IV access. For the intramuscular arm this will be the number or intramuscular doses, or where the clincian elects to give supplemental doses intravenously the sum of intramuscular doses and number of attempts to achieve IV access. The number of intramuscular doses will be collected from the medication administration record, the number of intravenous access attempts will be recorded by nursing staff on the study case report form (CRF).
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Assessment method [4]
369269
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Timepoint [4]
369269
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End of procedure
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Secondary outcome [5]
369270
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Adverse event rates including (but not limited to) apnoea, hypoxaemia, bradycardia, hypotension, excess oral or nasal secretions, emergence phenomena requiring medical treatment, vomiting, pulmonary aspiration or adverse drug reaction as routinely recorded on the procedural sedation record and in the patients medical record.
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Assessment method [5]
369270
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Timepoint [5]
369270
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Discharge from the emergency department
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Eligibility
Key inclusion criteria
Each patient must meet all the following criteria to be enrolled in this study
- Between the ages of 1 and 12 years
- Requires procedural sedation with ketamine (as determined by the treating clinician) to manage their presenting complaint
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the patient’s behalf.
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Minimum age
1
Years
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Maximum age
12
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
Patients meeting any of the following criteria will be excluded from the study:
- has a known or suspected allergy, hypersensitivity or contraindication to ketamine;
- Requires a IV cannula for other therapy, such as intravenous antibiotics, fluids or analgesia.
- Weight greater than 50kg
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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)
Randomisation will be web-based and age-stratified. The doctor enrolling the child, after obtaining informed consent, will attend the randomisation webpage, enter the child’s age, and obtain the allocation when the patient is ready for the procedure.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician not directly involved in the analysis of the study results will prepare the randomisation schedule using block randomisation to maintain balance between treatment arms. Treatment allocations to each group will be equal.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Data will be analysed by intention-to-treat methods. The statistician will be blinded to route allocation (IV or IM). Baseline descriptive statistics (either mean [standard deviation], median [interquartile range] or n [%] dependent on variable distribution) will be presented for each group and stratum, however following best practice will not be statistically compared.
Chi-squared or Fisher’s exact test will be used to compare rates between the study groups (and by age group where relevant); risk ratios and 95% confidence intervals will be presented for primary and secondary outcomes where appropriate. Continuous data will be analysed using either t-test or Mann-Whitney U test dependent on variable distribution.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/06/2019
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Actual
31/07/2019
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Date of last participant enrolment
Anticipated
30/04/2024
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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
537
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Accrual to date
361
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
13600
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Gold Coast University Hospital - Southport
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Recruitment hospital [2]
13601
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Logan Hospital - Meadowbrook
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Recruitment postcode(s) [1]
26262
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4215 - Southport
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Recruitment postcode(s) [2]
26263
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4131 - Meadowbrook
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Funding & Sponsors
Funding source category [1]
302453
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Charities/Societies/Foundations
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Name [1]
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Emergency Medicine Foundation
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Address [1]
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2/15 Lang Parade, Milton QLD 4064
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Country [1]
302453
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Australia
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Primary sponsor type
Hospital
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Name
Gold Coast Hospital and Health Service
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Address
1 Hospital Blvd
Southport, Qld 4215
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Country
Australia
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Secondary sponsor category [1]
302356
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None
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Name [1]
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N/A
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Address [1]
302356
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N/A
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Country [1]
302356
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Other collaborator category [1]
280632
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University
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Name [1]
280632
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The University of Queensland
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Address [1]
280632
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Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
South Brisbane, Qld 4101
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Country [1]
280632
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303122
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Children Health Queensland Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
303122
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Level 7, Centre for Children's Health Research
62 Graham Street
South Brisbane, Qld 4101
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Ethics committee country [1]
303122
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Australia
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Date submitted for ethics approval [1]
303122
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08/01/2019
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Approval date [1]
303122
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18/02/2019
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Ethics approval number [1]
303122
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HREC/19/QCHQ/45015
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Summary
Brief summary
Procedural sedation in children is a commonly performed task in mixed emergency departments around Australia. Ketamine has gained significant acceptance as the drug of choice to conduct this sedation. The preferred route of ketamine administration is an ongoing debate. Historically intravenous ketamine sedation has been favoured, however the evidence is not strong and mostly based on anecdotes. Further, the initial intravenous cannulation required has the negative consequence of inducing significant pain and distress.
Aim
To demonstrate in a randomised control trial that intramuscular ketamine, given in one needle, can achieve successful procedural sedation in children.
Research Design
This is an open label multicentre randomised control trial investigating whether paediatric procedural sedation can be achieved with just one needle. Study sites include Gold Coast University Hospital and Logan Hospital - 537 participants will be enrolled. Patients 1-12 yrs of age presenting to emergency department and requiring procedural sedation with ketamine (as determined by the senior treating clinician) will be eligible for inclusion into the study. Exclusion criteria will include the lack of informed consent and intravenous cannulation being required for another aspect of their management. The study has two intervention arms, one arm will receive 3mg/kg and the other arm will receive 4mg/mg via intramuscular injection. Participants will be randomised in a 1:1:1 ratio between the two intervention arms and control. Intramuscular injections will be administered by the treating doctor or nurse. Where adequate sedation to undertake the required procedure is not achieved with the initial intramuscular dose, additional intramuscular or intravenous doses of ketamine will be administered at treating clinician discretion.. Patients in the control group will be intravenously cannulated and ketamine given initially at 1mg/kg and then dose titrated to effect at the treating clinician’s discretion. The primary outcome will be success of paediatric procedural sedation with only one needle. Secondary outcomes include length of stay in the emergency department, length of sedation and adverse effects in the intramuscular versus intravenous groups.
Significance
This multicentre randomised trial will allow definitive assessment of the efficacy of a one needle approach giving intramuscular ketamine to achieve paediatric procedural sedation in children, with the goal of minimising unnecessary distress.
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Trial website
N/A
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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 Shane George
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Address
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Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101
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Country
92546
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Australia
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Phone
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+61 418731972
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Fax
92546
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Email
92546
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[email protected]
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Contact person for public queries
Name
92547
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Dr Shane George
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Address
92547
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Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101
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Country
92547
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Australia
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Phone
92547
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+61 418731972
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Fax
92547
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Email
92547
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[email protected]
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Contact person for scientific queries
Name
92548
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Dr Shane George
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Address
92548
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Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101
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Country
92548
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Australia
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Phone
92548
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+61 418731972
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Fax
92548
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Email
92548
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All available non-identifiable data will be shared on request, where it complies with local regulatory conditions and complies with ethics committee approvals.
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When will data be available (start and end dates)?
Data will be available from the date of manuscript publication for a period of 5 years. In the unlikely event that the manuscript is not accepted for publication, data will be available for 5 years from the conclusion of the study.
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Available to whom?
Data will be available from the chief investors upon request by email.
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Available for what types of analyses?
Any purpose that is allowable by local regulatory conditions and ethics committee approvals.
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How or where can data be obtained?
Data will be made available electronically, via secure file transfer.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5572
Study protocol
[email protected]
5573
Informed consent form
[email protected]
5574
Ethical approval
[email protected]
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.
Download to PDF