POSTOP NAUSEA VOMITINGNCT03879681
SNAKES Trial: Jelly Snakes to Prevent PONV in Kids After ENT Surgery
A study testing Jelly confectionary Snakes in people with POSTOP NAUSEA VOMITING and Tonsillectomy, run by Prof. Thomas Engelhardt.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- POSTOP NAUSEA VOMITING, Tonsillectomy, Adenoidectomy
- What is being tested?
- Jelly confectionary Snakes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Volatile anaesthetic-based general anaesthesia
- Written informed parental consent
- Elective tonsillectomy +/- adenoidectomy (+/- myringotomy, EUA ear, grommets or cautery of inferior turbinates')
Who cannot join
- Plan to use muscle relaxant
- Plan to use topical lignocaine on the vocal cords intraoperatively
- 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), children with diabetes and vegetarian children
- Contraindication to any protocolised anti-emetic drug (prophylaxis, intervention or rescue)
- Parents/guardians or children who, in the opinion of the investigator, may be unable to understand or give informed consent will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SNAKES UK: a Pilot Trial of Jelly Snakes to Prevent Postoperative Nausea and Vomiting in Kids After ENT Surgery
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. 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 the investigators 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. The investigators 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 the investigators' 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.
Read the detailed description
Primary Hypothesis Chewing large jelly snakes will significantly reduce the development of postoperative vomiting in paediatric patients in the first 6 hours after volatile anaesthetic-based general anaesthesia for tonsillectomies +/- adenoidectomies.
Secondary Hypotheses:
- Jelly snakes will reduce the incidence of nausea in the first 6 hours after tonsillectomy +/- adenoidectomy surgery
- Jelly snakes will reduce rescue treatments for PONV in the first 6 hours
- Jelly snakes will reduce the incidence of PONV in the first 24 hours or up until discharge in case of tonsillectomies (whatever occurs first)
- Jelly snakes will reduce rescue treatments for PONV in the first 24 hours or up until discharge in case of tonsillectomies (whatever occurs first)
Safety Hypotheses:
Children will be able to chew and swallow jelly snakes post-surgery. No jelly snake or parts thereof will be inhaled in those receiving treatment.
Aims This pilot study aims to investigate if chewing jelly confectionary snakes after tonsillectomies +/- adenoidectomies will significantly reduce the incidence of postoperative nausea/vomiting (PONV) in children.
Study Design One site pilot trial of the effectiveness of chewy jelly snakes in the prevention of POV involving the Royal Aberdeen Children Hospital, UK.
- Conditions
- POSTOP NAUSEA VOMITING, Tonsillectomy, Adenoidectomy
- Being tested
- Jelly confectionary Snakes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jelly confectionary SnakesDietary supplement
The participants will be randomized by computer generated randomisation to receive either the jelly snake (n=120) or no intervention (n=120) apart from standard institutional management.
All children randomised into the snake group will be offered a chewy jelly snake once alert and cooperative in PACU or on the ward once University of Michigan Sedation Scale (UMSS) is 025,26. The UMSS is a simple observational tool that assesses the level of alertness on a five-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation).
The children randomized into the control group will receive a chewy jelly snake as a treat at discharge.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | Not described |
| Jelly Snakes | Experimental | Not described Receives: Dietary Supplement: Jelly confectionary Snakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative vomiting in paediatric patients in the first 6 hours after volatile anaesthetic-based general anaesthesia for adenoidectomies and / or tonsillectomies
Measured: up to 6 hours after the end of the surgery
Secondary outcomes (6)
Incidence of nausea in the first 6 hours post tonsillectomy +/- adenoidectomy surgery in children over 8 years
Measured: up to 6 hours after the surgery
• Number of rescue treatments for PONV in the first 6 hours
Measured: up to 6 hours after the surgery
• Incidence of PONV in the first 24 hours or up until discharge (whatever occurs first)
Measured: Up to 24 hours
• Time to first vomit if applicable (measured from arrival in PACU)
Measured: Up to 24 hours
• Time to first meal
Measured: Up to 24 hours
• Duration of hospital stay
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POSTOP NAUSEA VOMITINGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Thomas Engelhardt
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Prof. Thomas Engelhardt, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879681
- Sponsor's protocol ID
- Snakes UK
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNAKES UK: a Pilot Trial of Jelly Snakes to Prevent Postoperative Nausea and Vomiting in Kids After ENT Surgery
- ClinicalTrials.gov ID
- NCT03879681
- Acronym / sponsor ID
- Snakes UK
- Conditions
- POSTOP NAUSEA VOMITING, Tonsillectomy, Adenoidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Prof. Thomas EngelhardtOther government
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 the investigators 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. The investigators 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 the investigators' 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.
Detailed description
Primary Hypothesis Chewing large jelly snakes will significantly reduce the development of postoperative vomiting in paediatric patients in the first 6 hours after volatile anaesthetic-based general anaesthesia for tonsillectomies +/- adenoidectomies.
Secondary Hypotheses:
- Jelly snakes will reduce the incidence of nausea in the first 6 hours after tonsillectomy +/- adenoidectomy surgery
- Jelly snakes will reduce rescue treatments for PONV in the first 6 hours
- Jelly snakes will reduce the incidence of PONV in the first 24 hours or up until discharge in case of tonsillectomies (whatever occurs first)
- Jelly snakes will reduce rescue treatments for PONV in the first 24 hours or up until discharge in case of tonsillectomies (whatever occurs first)
Safety Hypotheses:
Children will be able to chew and swallow jelly snakes post-surgery. No jelly snake or parts thereof will be inhaled in those receiving treatment.
Aims This pilot study aims to investigate if chewing jelly confectionary snakes after tonsillectomies +/- adenoidectomies will significantly reduce the incidence of postoperative nausea/vomiting (PONV) in children.
Study Design One site pilot trial of the effectiveness of chewy jelly snakes in the prevention of POV involving the Royal Aberdeen Children Hospital, UK.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | – |
| Jelly Snakes | Experimental | Dietary Supplement: Jelly confectionary Snakes |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Volatile anaesthetic-based general anaesthesia
- Written informed parental consent
- Elective tonsillectomy +/- adenoidectomy (+/- myringotomy, EUA ear, grommets or cautery of inferior turbinates')
Key exclusion criteria (5 listed)
- Plan to use muscle relaxant
- Plan to use topical lignocaine on the vocal cords intraoperatively
- 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), children with diabetes and vegetarian children
- Contraindication to any protocolised anti-emetic drug (prophylaxis, intervention or rescue)
- Parents/guardians or children who, in the opinion of the investigator, may be unable to understand or give informed consent will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jelly confectionary SnakesThe participants will be randomized by computer generated randomisation to receive either the jelly snake (n=120) or no intervention (n=120) apart from standard institutional management. All children randomised into the snake group will be offered a chewy jelly snake once alert and cooperative in PACU or on the ward once University of Michigan Sedation Scale (UMSS) is 025,26. The UMSS is a simple observational tool that assesses the level of alertness on a five-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). The children randomized into the control group will receive a chewy jelly snake as a treat at discharge. | Dietary supplement | Jelly Snakes |
Primary outcome
Incidence of postoperative vomiting in paediatric patients in the first 6 hours after volatile anaesthetic-based general anaesthesia for adenoidectomies and / or tonsillectomies
Time frame: up to 6 hours after the end of the surgery
6 secondary outcomes
Incidence of nausea in the first 6 hours post tonsillectomy +/- adenoidectomy surgery in children over 8 years
Time frame: up to 6 hours after the surgery
• Number of rescue treatments for PONV in the first 6 hours
Time frame: up to 6 hours after the surgery
• Incidence of PONV in the first 24 hours or up until discharge (whatever occurs first)
Time frame: Up to 24 hours
• Time to first vomit if applicable (measured from arrival in PACU)
Time frame: Up to 24 hours
• Time to first meal
Time frame: Up to 24 hours
• Duration of hospital stay
Time frame: Up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Jelly confectionary Snakes in people with POSTOP NAUSEA VOMITING and Tonsillectomy, run by Prof. Thomas Engelhardt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Engelhardt, Prof ((0044) 1224 550128, t.engelhardt@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative vomiting in paediatric patients in the first 6 hours after volatile anaesthetic-based general anaesthesia for adenoidectomies and / or tonsillectomies (time frame: up to 6 hours after the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.