About this trial
Fasting is a requirement to safely anesthetise patients referred for elective procedure, using the traditional 6/4/2 rule (6h for solid food or formula milk, 4h for breast milk and 2h for clear fluids), applied to all patients regardless of their age or weight. Reducing the aspiration risk however puts young children at higher risk of hypoglycemia due to the immaturity of their endocrine system and absence of metabolic reserves. The Association of Paediatric Anaesthetists of Great Britain and Ireland recommends that during day case surgery the majority of children may be given fluids without dextrose, provided blood glucose is monitored. Recent statements recommend continuing fluids until 1h before the procedure or even to give fluids when anesthetists sent for the patients. Hypoglycemia is rare in children above 2 years of age. Although the definition of hypoglycemia can differ, a threshold of 3.6mmol/l is often used given the potential neurological harm existing below this value. There is no consensus on the definition of hypoglycemia in children being fasted prior to general anesthesia, nor when nor how to treat it. Measurements are done for complex surgeries or patients deemed at risk according to the anesthetists. An audit was run in 2017 at the " Evelina London Children's Hospital ", Guy's and St Thomas' National Health Service Foundation Trust, identifying 8% of children below 2 years of age as hypoglycemic. Recent review of our Incident Reporting Systems identified 3 cases, in otherwise fit and healthy children, referred for colonoscopy with initial hypoglycemia followed by rebound hypoglycemia after management. There is an urgent need to establish a clear definition of hypoglycemia and investigate risk factors in paediatric patients referred for elective procedures under general anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All American Society of Anesthesiology score (ASA) 1 - 3 children aged 1 month to 18 years presenting for an elective procedure involving general anaesthesia during the defined study period
All elective cases, day cases will be included (patient's admitted the night before for bowel preparation prior to elective colonoscopy should also be included)
Planned expedited cases in ASA 1 / 2 children should be included, for example nail bed repairs, lacerations, foreign body (in ear / eye / nose), simple fractures for manipulation under anesthesia / k-wires
MRI, radiology and dental cases will be included provided the patient receives a general anaesthetic
Disqualifiers
Children aged less than 1 month
Procedures performed under oral sedation or local anaesthesia only
ASA status 4 and 5
Type 1 or 2 diabetes mellitus, medium chain acetyl Co-enzyme A, maple syrup urine disease, glycogen storage disease, galactosaemia, urea cycle defects, familial hypercholesterolaemia, congenital disorders of glycosylation, lysosomal storage disorders, organic acidaemias, mitochondrial disorders, adrenal gland disorders, adrenoleukodystrophy, growth disorders, lipid disorders, multiple endocrine neoplasia type 1 and 2, pituitary disorders.
Trial population
Pediatric patients fasting for a procedure under general anesthesia
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Clinical definition if hypoglycemia
Blood glucose values triggering a response from the anaesthetists with initiation of a hypoglycaemia treatment following a blood glucose measurement during anaesthetic induction
Secondary outcomes
4mmol/l as a suitable threshold of hypoglycemia
Number of patient with a blood glucose measurement below 4mmol/l and being treated as hypoglycaemic by an anaesthetist following a blood glucose measurement during anaesthetic induction
Distribution of glycemic measurements in fasting children
Blood glucose values in children undergoing elective procedure under general anaesthesia.
Age as a risk factor of hypoglycaemia
Number of children below 24 months of age reported as hypoglycaemic by an anaesthetist following a blood glucose measurement during anaesthetic induction
Weight as a risk factor of hypoglycaemia
Number of children weighing less than 10kg and considered as hypoglycaemic by an anaesthetist following a blood glucose measurement during anaesthetic induction
Sponsors and contacts
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Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
Evelina London Children's Charity
Collaborator
Nova Biomedical
Collaborator
Kings Health Partners
Collaborator