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Trial registered on ANZCTR
Registration number
ACTRN12624000854538
Ethics application status
Approved
Date submitted
8/05/2024
Date registered
10/07/2024
Date last updated
15/09/2024
Date data sharing statement initially provided
10/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A single-group pilot trial evaluating the effect of pre-procedural chewables on gastric volume and ease of fasting in children undergoing surgery (JELLYFISH - Phase One)
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Scientific title
A single-group pilot trial evaluating the effect of pre-procedural chewables on gastric volume and ease of fasting in children undergoing surgery (JELLYFISH - Phase One)
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Secondary ID [1]
311886
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NIL
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Universal Trial Number (UTN)
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Trial acronym
JELLYFISH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pre-operative fasting
333462
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Condition category
Condition code
Anaesthesiology
330133
330133
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0
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Anaesthetics
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Alternative and Complementary Medicine
330134
330134
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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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 comes 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 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 first phase of a two-phase trial. This phase will evaluate the efficacy of the tablets in children undergoing upper gastrointestinal endoscopic examination.
This phase will involve recruiting 20 patients scheduled for an upper gastrointestinal endoscopy. All children will be offered 20 pre-procedural chewables a maximum of four hours prior to the scheduled procedure time. Participants can consume as many of these chewables as they like until one hour prior to the scheduled procedure time. The total volume for 20 of the pre-procedural chewables is approximately 9mls. This quantity is well below the permitted 3mls/kg of clear fluid allowed at 1hr prior to surgery. Aside from the pre-procedural chewables, participants will be fasted in line with current Perth Children’s Hospital institutional guidelines. Participants will be allowed to consume 3 mLs/kg per hour clear liquid (water, apple juice or lemonade) until one hour prior to surgery.
The gastroenterologist performing the procedure will visually assess the presence/absence of the pre-procedural chewables in the stomach during the procedure. Furthermore, the amount of gastric volume will be assessed through suctioning of stomach contents at the start of the procedure. Participants will be assessed post-operatively for the incidence of any post-operative nausea and vomiting. Parents/guardians of participants will receive a link to a short follow-up survey 24-48 hours after their procedure asking them to appraise their ease of fasting, and whether they think the intervention helped them with fasting.
Parents will be asked how many chewables their child consumes.In order to adequately assess the in-vivo dissolution of the pre-procedural chewables any child who has not eaten all 20 chewables will be replaced until 20 participants are recruited who have consumed 20 chewables.
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Intervention code [1]
328352
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Assess the in-vivo dissolution of the fasting pre-procedural chewables in children undergoing upper gastrointestinal endoscopies.
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Assessment method [1]
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Gastroenterologist performing scope will visually assess the stomach for evidence of undissolved particles. Assessed on a binary scale - yes if there is evidence of undissolved particles, no if there is not.
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Timepoint [1]
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Assessed during the endoscopy.
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Primary outcome [2]
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Assess the impact of the pre-procedural chewables on gastric volume.
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Assessment method [2]
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Suctioning the contents of the stomach and measuring the volume.
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Timepoint [2]
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Suctioning will occur at the start of the endoscopy.
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Primary outcome [3]
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Acceptance of the fasting chewables of fasting children
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Assessment method [3]
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Five point Likert scale from 1 (very dissatisfied) to 5 (very satisfied) with pre-operative fasting.
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Timepoint [3]
337892
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Children will be asked post-operatively on the day of surgery.
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Secondary outcome [1]
433607
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Assess the acceptance of the fasting chewables to parents of fasting children scheduled for surgery.
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Assessment method [1]
433607
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Five point Likert scale from 1 (very dissatisfied) to 5 (very satisfied) with pre-operative fasting.
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Timepoint [1]
433607
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Parents will be asked post-operatively on the day of surgery.
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Secondary outcome [2]
433608
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Assessment of post-operative nausea and vomiting (PONV) in children undergoing upper gastrointestinal endoscopy who have been given the pre-procedural chewables.
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Assessment method [2]
433608
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Any incidence of nausea, vomitting and/or retching will be recorded on a binary scale (yes if it occurred, no if it did not occur).
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Timepoint [2]
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Assessed in the first 6 hours after their procedure or until discharge from hospital.
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Secondary outcome [3]
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Assessment of the ease of fasting in children undergoing upper gastrointestinal endoscopy who have been given the pre-procedural chewables.
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Assessment method [3]
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Participants will be asked to assess ease of fasting using a five-point scale (very easy, easy, neither easy nor hard, hard, very hard)
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Timepoint [3]
435926
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Participants will be emailled a survey to be completed 24-48 hours post-procedure.
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Secondary outcome [4]
435929
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Assessment of the ease of fasting in parents of children undergoing upper gastrointestinal endoscopy who have been given the pre-procedural chewables.
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Assessment method [4]
435929
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Participants will be asked to assess ease of fasting using a five-point scale (very easy, easy, neither easy nor hard, hard, very hard)
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Timepoint [4]
435929
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Participants will be emailled a survey to be completed 24-48 hours post-procedure.
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Secondary outcome [5]
435931
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Assessment of how much participants liked the chewables
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Assessment method [5]
435931
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A five point likert scale from "disliked a lot" to "liked a lot"
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Timepoint [5]
435931
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Participants will be asked post-operatively on the day of surgery.
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Secondary outcome [6]
435932
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Assessment of how hungry and thirsty participants felt prior to their surgery
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Assessment method [6]
435932
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A 3 point likert scale from "very hungry and thristy" to "not hungry or thirsty"
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Timepoint [6]
435932
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Participants will be asked post-operatively on the day of surgery.
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Secondary outcome [7]
435933
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Assessment of participant's fasting discomfort.
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Assessment method [7]
435933
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A 3 point likert scale from "very uncomfortable" to "not uncomfortable"
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Timepoint [7]
435933
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Participants will be asked post-operatively on the day of surgery.
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Eligibility
Key inclusion criteria
Phase One; Children aged 3 to 16 years undergoing electic upper gastrointestinal endoscopy
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Minimum age
3
Years
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Maximum age
16
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
Phase One:
• Known allergy to ingredients of pre-procedural chewables
• Children with diabetes
• Patients undergoing urgent procedures (gastrointestinal bleeding, oesophageal foreign body)
• Patients with known or suspected delayed gastric emptying.
• Children undergoing colonoscopy in addition to endoscopy
• Children with pre-existing gastro-oesophageal reflux
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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.
Phase One
The primary outcome is the presence/absence of residue from the chewable tables in the stomach (binary: yes/no). The numbers of participants with chewable residue present in the stomach will be reported.
Secondary outcome variables for this phase will be summarised in each group.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
24/09/2024
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Actual
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Date of last participant enrolment
Anticipated
31/10/2024
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Actual
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Date of last data collection
Anticipated
31/10/2024
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
26520
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
42561
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
316234
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Hospital
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Name [1]
316234
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Perth Children's Hospital
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Address [1]
316234
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Country [1]
316234
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Australia
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Funding source category [2]
316461
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Charities/Societies/Foundations
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Name [2]
316461
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Telethon Trust
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Address [2]
316461
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Country [2]
316461
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Australia
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Funding source category [3]
316462
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Government body
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Name [3]
316462
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WA Department of Health
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Address [3]
316462
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Country [3]
316462
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
The Kids Research Institute Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
318424
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None
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Name [1]
318424
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Address [1]
318424
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Country [1]
318424
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315057
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [1]
315057
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15 Hospital Avenue Nedlands Western Australia 6009
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Ethics committee country [1]
315057
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Australia
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Date submitted for ethics approval [1]
315057
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26/02/2024
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Approval date [1]
315057
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03/05/2024
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Ethics approval number [1]
315057
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RGS0000006727
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Summary
Brief summary
Pre-operative fasting is an important part of preparing for anaesthesia. Fasting reduces the volume and acidity of the stomach contents, which serves to reduce the risk of regurgitation and pulmonary aspiration. Fasting can be particularly stressful for young children, which can in turn lead to negative psychosocial and physiological outcomes. In this study, we wish to investigate if a pre-procedural carbohydrate-based chewables can help children to better tolerate pre-operative fasting.
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Trial website
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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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Prof Britta von Ungern-Sternberg
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Address
133530
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Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
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Country
133530
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Australia
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Phone
133530
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+61 420790101
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Fax
133530
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Email
133530
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[email protected]
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Contact person for public queries
Name
133531
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Britta von Ungern-Sternberg
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Address
133531
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Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
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Country
133531
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Australia
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Phone
133531
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+61 420790101
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Fax
133531
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Email
133531
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[email protected]
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Contact person for scientific queries
Name
133532
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Britta von Ungern-Sternberg
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Address
133532
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Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
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Country
133532
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Australia
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Phone
133532
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+61 420790101
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Fax
133532
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Email
133532
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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)?
No
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No/undecided IPD sharing reason/comment
Investigators for the study are still deciding upon how to proceed with this and are awaiting feedback from their HREC.
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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.
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