A randomised controlled trial of pre-procedural chewables to help children fasting for surgery (JELLYFISH - Phase Two)

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.