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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.
Scientific title
One-Needle Approach to Paediatric Procedural Sedation using Ketamine: A Randomised Control Trial.
Secondary ID [1] 297938 0
Nil
Universal Trial Number (UTN)
U1111-1231-5033
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural Sedation 312327 0
Condition category
Condition code
Emergency medicine 310892 310892 0 0
Other emergency care
Anaesthesiology 311019 311019 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314161 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 319714 0
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.
Timepoint [1] 319714 0
At the completion of the procedure.
Secondary outcome [1] 369266 0
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.
Timepoint [1] 369266 0
Discharge from emergency department
Secondary outcome [2] 369267 0
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).
Timepoint [2] 369267 0
Time of change to standard level nursing care
Secondary outcome [3] 369268 0
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.
Timepoint [3] 369268 0
Time of discharge from the emergency department
Secondary outcome [4] 369269 0
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).
Timepoint [4] 369269 0
End of procedure
Secondary outcome [5] 369270 0
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.
Timepoint [5] 369270 0
Discharge from the emergency department

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.
Minimum age
1 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
31/07/2019
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
537
Accrual to date
361
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13600 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 13601 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 26262 0
4215 - Southport
Recruitment postcode(s) [2] 26263 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 302453 0
Charities/Societies/Foundations
Name [1] 302453 0
Emergency Medicine Foundation
Country [1] 302453 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
1 Hospital Blvd
Southport, Qld 4215
Country
Australia
Secondary sponsor category [1] 302356 0
None
Name [1] 302356 0
N/A
Address [1] 302356 0
N/A
Country [1] 302356 0
Other collaborator category [1] 280632 0
University
Name [1] 280632 0
The University of Queensland
Address [1] 280632 0
Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
South Brisbane, Qld 4101
Country [1] 280632 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303122 0
Children Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 303122 0
Level 7, Centre for Children's Health Research
62 Graham Street
South Brisbane, Qld 4101
Ethics committee country [1] 303122 0
Australia
Date submitted for ethics approval [1] 303122 0
08/01/2019
Approval date [1] 303122 0
18/02/2019
Ethics approval number [1] 303122 0
HREC/19/QCHQ/45015

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.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92546 0
Dr Shane George
Address 92546 0
Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101
Country 92546 0
Australia
Phone 92546 0
+61 418731972
Fax 92546 0
Email 92546 0
[email protected]
Contact person for public queries
Name 92547 0
Shane George
Address 92547 0
Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101
Country 92547 0
Australia
Phone 92547 0
+61 418731972
Fax 92547 0
Email 92547 0
[email protected]
Contact person for scientific queries
Name 92548 0
Shane George
Address 92548 0
Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101
Country 92548 0
Australia
Phone 92548 0
+61 418731972
Fax 92548 0
Email 92548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
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.
Available to whom?
Data will be available from the chief investors upon request by email.
Available for what types of analyses?
Any purpose that is allowable by local regulatory conditions and ethics committee approvals.
How or where can data be obtained?
Data will be made available electronically, via secure file transfer.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5572Study protocol  [email protected]
5573Informed consent form  [email protected]
5574Ethical approval  [email protected]



Results publications and other study-related documents

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