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)

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.