Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000853549
Ethics application status
Approved
Date submitted
28/05/2024
Date registered
10/07/2024
Date last updated
10/07/2024
Date data sharing statement initially provided
10/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of pre-procedural chewables to help children fasting for surgery (JELLYFISH - Phase Two)
Scientific title
A randomised controlled trial of pre-procedural chewables to help children fasting for surgery (JELLYFISH - Phase Two)
Secondary ID [1] 312189 0
NIL
Universal Trial Number (UTN)
Trial acronym
JELLYFISH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-operative fasting 333854 0
Condition category
Condition code
Anaesthesiology 330530 330530 0 0
Anaesthetics
Alternative and Complementary Medicine 330531 330531 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-centre, open-label, clinical trial at Perth Children’s Hospital to evaluate efficacy of pre-procedural chewables for use in pre-procedural fasting.

In this trial we will investigate pre-procedural carbohydrate-based chewables, which come in two flavours. One chewable is prepared using a blueberry-flavoured simple syrup and the other uses a vanilla-flavoured maple syrup.

The pre-procedural chewables are carbohydrate-rich solid chewables (1 x 1 x 0.5cm) which dissolve quickly and completely. The design principle was that of a “solid to clear liquid formulation in vivo” to comply with the anaesthetic fasting guidelines. The chewables are formulated to have the following properties:
- Rapid and complete dissolution in the mouth to become a clear liquid within 3 minutes
- Does not precipitate into particulate material in the acidic content of the stomach
- Safe to administer to young children
- Taste and texture that is acceptable to young children.
- Physically stable for transport and storage at ambient conditions

The ingredients in the pre-procedural chewables are food ingredients purchased from registered Australian suppliers. Further information cannot be supplied at this stage for confidentiality reasons.

The chewables are packaged in a sealed plastic bag.

The chewables will be manufactured in the WA Hospitals Central Pharmaceutical Manufacturing Facility (Auspman). The chewables will adhere to acceptable pharmaceutical standards and the quality of the chewables will be confirmed through various tests, including batch reproducibility, dissolution time in simulated saliva, precipitation in simulated gastric, mechanical integrity during storage and transport, texture and appearance. Auspman is located in Balcatta, WA and is the manufacturing arm of the Pharmacy Department at Perth Children’s Hospital.

This is the second phase of a two-phase trial. This phase will evaluate the effectiveness of the chewables at relieving fasting discomfort. 300 children undergoing elective, surgical procedures will be recruited at Perth Children’s Hospital. These children will be randomised to receive either the pre-procedural chewables (interventional group), DEX(TM) (comparator group) or standard clinical care (no fasting intervention - control group).

Children in the interventional group will be given 20 chewables to consume during the pre-operative fasting period from admission to hospital (after consent) until 1 hour prior to the procedure time. Children can consume as many of the 20 chewables as they wish. Any remaining chewables will be removed one hour prior to the scheduled procedure time. Research staff will note how many chewables the patient consumes during this time.

The comparator group will be 100 children randomised to receive DEX complex carbohydrate drink prior to their procedure. DEX contains water, maltodextrin, natural peach flavour and sodium citrate. Participants in this group will be given the DEX when they arrive in the pre-operative holding area. These chlidren will be allowed 3ml/kg to consume as they wish up until one hour prior to the procedure time. The volume of DEX consumed will be monitored by the research team.


Intervention code [1] 328638 0
Treatment: Other
Comparator / control treatment
The control group will be 100 children randomised to receive standard fasting care. These participants will be allowed up to 3ml/kg clear fluid until 1 hour prior to the scheduled procedure time. The volume of fluid consumed will be monitored by the research team.

Children's fasting will be monitored by the preoperative nursing team and research staff.
Control group
Active

Outcomes
Primary outcome [1] 338296 0
Assess the acceptance of the fasting chewables to parents of fasting children scheduled for surgery.
Timepoint [1] 338296 0
Parents will be asked post-operatively on the day of surgery.
Primary outcome [2] 338297 0
Effectiveness of the pre-procedural fasting chewables at alleviating fasting discomfort in children scheduled for surgery at Perth Children's Hospital
Timepoint [2] 338297 0
Children will be asked post-operatively on the day of surgery.
Secondary outcome [1] 435321 0
Acceptance of the fasting chewables to fasting children
Timepoint [1] 435321 0
Children will be asked post-operatively on the day of surgery.
Secondary outcome [2] 435322 0
Assessment of post-operative nausea and vomiting (PONV) in children undergoing surgery who are given pre-procedural chewables pre-operatively.
Timepoint [2] 435322 0
Assessed in the first 6 hours after their procedure or until discharge from hospital.
Secondary outcome [3] 435323 0
Assessment of post-operative nausea and vomiting (PONV) in children undergoing surgery who are given standard treatment
Timepoint [3] 435323 0
Assessed in the first 6 hours after their procedure or until discharge from hospital.
Secondary outcome [4] 435324 0
Assessment of post-operative nausea and vomiting (PONV) in children undergoing surgery who are given DEX preoperative fasting drink preoperatively.
Timepoint [4] 435324 0
Assessed in the first 6 hours after their procedure or until discharge from hospital.
Secondary outcome [5] 435947 0
Assessment of the ease of fasting in participants.
Timepoint [5] 435947 0
Participants will be emailled a survey to be completed 24-48 hours post-procedure.
Secondary outcome [6] 435948 0
Assessment of the ease of fasting in parents of participants.
Timepoint [6] 435948 0
Participants will be emailled a survey to be completed 24-48 hours post-procedure.
Secondary outcome [7] 435949 0
Child's assessment of how much the chewables helped with fasting
Timepoint [7] 435949 0
Participants will be asked post-operatively on the day of surgery.
Secondary outcome [8] 435950 0
Assessment of anxiety and behaviour in children undergoing surgery.
Timepoint [8] 435950 0
Behaviour will be assessed just before checkout from ward to theatre and again at induction.
Secondary outcome [9] 436186 0
Blood glucose levels in children undergoing surgery
Timepoint [9] 436186 0
Measured immediately following the induction of anaesthesia.
Secondary outcome [10] 436187 0
Ketone levels in children undergoing surgery
Timepoint [10] 436187 0
Measured immediately following the induction of anaesthesia.
Secondary outcome [11] 436188 0
Number of chewables consumed by patients allocated to recieve the chewables pre-operatively.
Timepoint [11] 436188 0
Parents will be asked 1 hour before the scheduled procedure time, when the chewables will be removed from the child.

Eligibility
Key inclusion criteria
Children aged 3 to 16 years scheduled for elective day-stay surgery under general anaesthesia at Perth Children’s Hospital who are ASA (American Society of Anaesthesiologists) physical scale 1 or 2
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known allergy to ingredients of pre-procedural chewables
• Children with diabetes
• Children with pre-existing gastro-oesophageal refl ux
• Children with suspected/delayed gastric emptying or oesphageal pathologies associated with gastroesophageal reflux or known recurrent aspiration

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)
Centralised computer generated block randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be monitored for fidelity as the trial progresses. Statistical analysis will be performed in the R statistical environment (http://www.Rproject.org). Continuous data will be summarized using the mean (SD), or median (interquartile range) if skewed, and categorical data using counts (%). Significance will be assessed at p<0.05.

The primary outcome is parent satisfaction with preoperative fasting, answered on a Likert scale with values from 1 (very dissatisfied) to 5 (very satisfied). The data will be explored by examining proportions in each level, cross-tables with other categorical variables (such as sex) and plots against continuous covariates (such as BMI). A linear statistical model will be fitted to patient satisfaction against the treatment (chewables, DEX and standard care). to examine any differences in mean satisfaction score. Available demographics will be included in the model. Similarly, comfort score will be modelled to determine any differences in mean comfort between the chewables, DEX and standard care.

Secondary outcomes for this phase will be compared between groups using appropriate models (a Poisson regression of logistic regression) based on the type of outcome data (a count or presence/absence) will be fitted to each outcome, with treatment (standard care, DEX and the pre-procedural chewables) entered as an explanatory variable, and clinically relevant patient and medical characteristics entered as covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/08/2024
Actual
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
6/12/2024
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26561 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 42603 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 316561 0
Hospital
Name [1] 316561 0
Perth Children's Hospital
Country [1] 316561 0
Australia
Funding source category [2] 316562 0
Charities/Societies/Foundations
Name [2] 316562 0
Telethon Trust
Country [2] 316562 0
Australia
Funding source category [3] 316563 0
Government body
Name [3] 316563 0
WA Department of Health
Country [3] 316563 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
Country
Australia
Secondary sponsor category [1] 318741 0
None
Name [1] 318741 0
Address [1] 318741 0
Country [1] 318741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315351 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315351 0
Ethics committee country [1] 315351 0
Australia
Date submitted for ethics approval [1] 315351 0
26/02/2024
Approval date [1] 315351 0
03/05/2024
Ethics approval number [1] 315351 0
RGS0000006727

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

Contacts
Principal investigator
Name 134426 0
Prof Britta von Ungern-Sternberg
Address 134426 0
Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
Country 134426 0
Australia
Phone 134426 0
+61 420790101
Fax 134426 0
Email 134426 0
[email protected]
Contact person for public queries
Name 134427 0
Britta von Ungern-Sternberg
Address 134427 0
Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
Country 134427 0
Australia
Phone 134427 0
+61 420790101
Fax 134427 0
Email 134427 0
[email protected]
Contact person for scientific queries
Name 134428 0
Britta von Ungern-Sternberg
Address 134428 0
Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
Country 134428 0
Australia
Phone 134428 0
+61 420790101
Fax 134428 0
Email 134428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Investigators for the study are still deciding upon how to proceed with this.


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.