ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1231-5033

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Procedural Sedation

Condition category

Condition code

Emergency medicine

Other emergency care

Anaesthesiology

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]

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]

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]

At the completion of the procedure.

Secondary outcome [1]

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]

Discharge from emergency department

Secondary outcome [2]

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]

Time of change to standard level nursing care

Secondary outcome [3]

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]

Time of discharge from the emergency department

Secondary outcome [4]

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]

End of procedure

Secondary outcome [5]

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]

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?

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]

Gold Coast University Hospital - Southport

Recruitment hospital [2]

Logan Hospital - Meadowbrook

Recruitment postcode(s) [1]

4215 - Southport

Recruitment postcode(s) [2]

4131 - Meadowbrook

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Emergency Medicine Foundation

Address [1]

2/15 Lang Parade, Milton QLD 4064

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Other collaborator category [1]

University

Name [1]

The University of Queensland

Address [1]

Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
South Brisbane, Qld 4101

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children Health Queensland Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 7, Centre for Children's Health Research
62 Graham Street
South Brisbane, Qld 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/01/2019

Approval date [1]

18/02/2019

Ethics approval number [1]

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

Dr Shane George

Address

Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101

Country

Australia

Phone

+61 418731972

Fax

shane.george@uq.edu.au

Contact person for public queries

Name

Shane George

Address

Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101

Country

Australia

Phone

+61 418731972

Fax

shane.george@uq.edu.au

Contact person for scientific queries

Name

Shane George

Address

Paediatric Critical Care Research Group
Child Health Research Centre
The University of Queensland
62 Graham St
South Brisbane, Qld 4101

Country

Australia

Phone

+61 418731972

Fax

shane.george@uq.edu.au

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.	Type	Email
5572	Study protocol	Shane.George@uq.edu.au
5573	Informed consent form	Shane.George@uq.edu.au
5574	Ethical approval	Shane.George@uq.edu.au

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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