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Trial registered on ANZCTR


Registration number
ACTRN12618000637246
Ethics application status
Approved
Date submitted
18/04/2018
Date registered
23/04/2018
Date last updated
17/02/2020
Date data sharing statement initially provided
2/07/2019
Date results information initially provided
17/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
SNAKES: a pilot trial of Jelly Snakes to prevent postoperative Nausea and Vomiting in Kids after ENT Surgery
Scientific title
A pilot trial of confectionery Jelly Snakes to prevent postoperative Nausea and Vomiting in children after tonsillectomy and/or adenoidectomy Surgery.
Secondary ID [1] 294630 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SNAKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative Vomiting 307473 0
Post operative Nausea 307474 0
Condition category
Condition code
Anaesthesiology 306557 306557 0 0
Anaesthetics
Surgery 306558 306558 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be randomised by computer generated randomisation to receive either a confectionery jelly snake or no intervention apart from standard institutional management of anaesthesia.
The snakes to be administered are individually wrapped 50g confectionary Snakes. They will be given once the child is awake and in a non delirious state with a University of Michigan Sedation Scale (UMSS) score of 0. Compliance for eating the snake (or part thereof) will be observed and documented.
Intervention code [1] 300934 0
Prevention
Intervention code [2] 300970 0
Treatment: Other
Comparator / control treatment
The control group (50%) will receive no additional treatment (i.e. no jelly snake).
All participants will be receiving standard dual antiemetic prophylaxis with ondansetron and dexamethasone as per local institutional guidelines.
Control group
Active

Outcomes
Primary outcome [1] 305555 0
The Incidence of postoperative vomiting in paediatric patients in the first 6 hours after volatile anaesthetic-based general anaesthesia for adenoidectomies and / or tonsillectomies. This will be assessed by observation of the participant, a review of the participants medical notes on the day of surgery and also by questioning the parent/guardian on a follow up phone call.
Timepoint [1] 305555 0
In the first 6 hours post surgery.
Secondary outcome [1] 345745 0
The Incidence of nausea in the first 6 hours post tonsillectomy and/or adenoidectomy surgery in children over 8 years. This will be assessed by observation of the participant, a review of the participants medical notes on the day of surgery and also by questioning the parent/guardian on a follow up phone call.
Timepoint [1] 345745 0
6 hours post surgery
Secondary outcome [2] 345746 0
The Number of rescue treatments for post operative nausea and vomiting (composite outcome).
This will be assessed by a review of the participants medical notes on the day of surgery and also by questioning the treating medical team and also the parent/guardian on a follow up phone call.
Timepoint [2] 345746 0
In the first 6 hours post surgery
Secondary outcome [3] 345747 0
Incidence of post operative nausea and vomiting in the first 24 hours or up until discharge (whatever occurs first). (composite outcome).
This will be assessed by observation of the participant, a review of the participants medical notes at discharge and also by questioning the parent/guardian on a follow up phone call.
Timepoint [3] 345747 0
From surgery to discharge or 24 hours after the procedure (whichever comes first)
Secondary outcome [4] 345748 0
The number of rescue treatments for post operative nausea and vomiting in the first 24 hours or up until discharge (whatever occurs first).
(composite outcome).
This will be assessed by a review of the participants medical notes at discharge and also by questioning the treating medical team and also the parent/guardian on a follow up phone call.
Timepoint [4] 345748 0
In the first 24 hours or up until discharge (whatever occurs first)
Secondary outcome [5] 345749 0
The time to first vomit if applicable (measured from arrival in Post Anaesthesia Care Unit (PACU).
This will be assessed by direct observation of the participant.
Timepoint [5] 345749 0
From arrival in PACU ward until discharge or 24 hours later (which ever comes first)
Secondary outcome [6] 345750 0
The time to first meal.
This will be assessed by observation of the participant and a review of the participants medical notes.
Timepoint [6] 345750 0
From end of surgery until first meal time
Secondary outcome [7] 345751 0
The acceptability of jelly snakes immediately post operatively to patient, nurse, parent/caregiver.
This will be assessed by direction observation of the participant and questioning the participant and parent/guardian.
Timepoint [7] 345751 0
From end of surgery time until discharge
Secondary outcome [8] 345752 0
The duration of hospital stay.
This will be assessed by review of the hospital booking system which logs arrival times, surgery times, anaesthesia times and discharge times etc.
Timepoint [8] 345752 0
From end of surgery time until discharge time

Eligibility
Key inclusion criteria
Female and male patients
Aged 2-16 years if parents feel confident the children can eat a snake
Volatile anaesthetic-based general anaesthesia
Written informed parental consent
Elective tonsillectomy and/or adenoidectomy (+/- myringotomy, EUA ear, grommets or cautery of inferior turbinates’)
Minimum age
2 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anaesthetist plans to use a muscle relaxant
Contraindication to chewy jelly snakes or any of their components e.g. known allergy to any of the ingredients of the chewy jelly snakes or impaired pharyngeal/oesophageal function (e.g. bulbar palsy, achalasia) and children with diabetes
Contraindication to any protocolised anti-emetic drug (prophylaxis, intervention or rescue)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pilot multi centre
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Previous audits at Princess Margaret Hospital have shown that 20-24% of tonsillectomy patients vomit prior to discharge. To detect a moderate effect size with power 80% at a significance level of 5% requires a sample size of 100 for each group. Based on our significant experience in recruiting participants in this age range who are undergoing general anaesthesia for surgery, we anticipate a 20% drop out rate due to participant withdrawals or loss of data due to technical/medical reasons. We will therefore recruit 120 participants per group (total=240 patients). We anticipate approximately 20 children will experience vomiting in the control group. This pilot study will allow us to plan a larger, definitive trial in the future.
Statistical analysis will include a logistic regression model for the odds ratio of vomiting against the treatment (snakes or no snakes) and any other covariates that are available (such as age of child, previous medical history, type of procedure).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10737 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 10738 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [3] 10739 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [4] 10740 0
Subiaco Private Hospital - Subiaco
Recruitment postcode(s) [1] 22460 0
6009 - Nedlands
Recruitment postcode(s) [2] 22461 0
6150 - Murdoch
Recruitment postcode(s) [3] 22462 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 299247 0
Charities/Societies/Foundations
Name [1] 299247 0
Perth Children's Hospital Foundation
Address [1] 299247 0
Perth Children's Hospital
QEII Medical Campus
Nedlands
WA 6009
Country [1] 299247 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
QEII Medical Centre
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 298520 0
Individual
Name [1] 298520 0
Prof Britta von Ungern-Sternberg
Address [1] 298520 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
QEII Medical Campus
Nedlands
WA 6009
Country [1] 298520 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300168 0
Children and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 300168 0
Perth Children's Hospital
QEII Medical Campus
Nedlands
WA 6009
Ethics committee country [1] 300168 0
Australia
Date submitted for ethics approval [1] 300168 0
17/04/2018
Approval date [1] 300168 0
18/06/2018
Ethics approval number [1] 300168 0
Ethics committee name [2] 303740 0
Subiaco Private Hospital MAC
Ethics committee address [2] 303740 0
Subiaco Private Hospital
9/1 Salvado Road
Subiaco
WA 6008
Ethics committee country [2] 303740 0
Australia
Date submitted for ethics approval [2] 303740 0
25/06/2018
Approval date [2] 303740 0
10/08/2018
Ethics approval number [2] 303740 0
n/a

Summary
Brief summary
Postoperative nausea and vomiting in children is a common phenomenon, particularly after ear nose and throat (ENT) surgery. While it affects up to 80% of patients who do not receive preventative medication during their operation, more than 1 in 5 children still suffer from postoperative nausea and vomiting after tonsillectomy even when given 2 medications to prevent it (internal audit data). Nausea and vomiting after an operation (postoperatively) particularly following tonsillectomy can be very painful and distressing for the child and their carer. Vomiting may also increase the risk of postoperative bleeding, a serious complication after the surgery. Postoperative nausea and vomiting is not only one of the main reasons for prolonged hospital stay or re-admission in children; it is also one of the main reasons for dissatisfaction with anaesthesia in children and their families. In adults, a pilot study has found that chewing gum postoperatively can significantly reduce postoperative nausea and vomiting. Chewing and swallowing, results in increased activity in the gut and lessens the effects of medications given under anaesthesia that tend to slow the gut.

However, for young children particularly following anaesthesia, chewing gum may not be a safe option. Therefore in this pilot study we will investigate if chewing a large jelly confectionary snake after the anaesthetic will help to reduce nausea and vomiting. The children who are enrolled in the study will be randomised to receive a jelly snake or no jelly snake to chew once awake after the surgery. There will be no other changes to the standard management which will be in accordance to institutional guidelines. We will then compare the rates of vomiting between the children who did and did not receive a jelly snake to chew. We will also monitor other oral and food intake and requirements for painkillers, as well as for other potential problems (e.g. delayed discharge) after surgery.

The advantage of using a jelly snake is that it is a simple, inexpensive, non-drug treatment. Parents are very keen to avoid the use of drugs for their children and so would be open to the use of this new approach. For children the jelly snake offers something familiar and an enjoyable solution to their discomfort. The use of jelly snakes could also be a simple intervention that parents could do at home following day case surgery for other procedures. While the jelly snakes are high in sugar, they are comparable to the sugar content of a glass of fruit juice, flavoured milk or soft drinks. Generally, in our experience, the willingness of parents to allow their children to receive treats in the postoperative period is very high, particularly since all children have a significant time of fasting (at least 6 hours, often longer) for solid foods prior to surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82766 0
Prof Britta von Ungern-Sternberg
Address 82766 0
Perth Children's Hospital
QEII Medical Campus
Nedlands
WA 6009
Country 82766 0
Australia
Phone 82766 0
+61420790101
Fax 82766 0
Email 82766 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for public queries
Name 82767 0
Prof Britta von Ungern-Sternberg
Address 82767 0
Perth Children's Hospital
QEII Medical Campus
Nedlands
WA 6009
Country 82767 0
Australia
Phone 82767 0
+61420790101
Fax 82767 0
Email 82767 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for scientific queries
Name 82768 0
Prof Britta von Ungern-Sternberg
Address 82768 0
Perth Children's Hospital
QEII Medical Campus
Nedlands
WA 6009
Country 82768 0
Australia
Phone 82768 0
+61420790101
Fax 82768 0
Email 82768 0
Britta.Regli-VonUngern@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of research team processes
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary