Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorGuy's and St Thomas' NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Immediately/within five minutes after anesthesia induction

Secondary outcomes

1

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

Time frame
Immediately/within five minutes after anesthesia induction
2

Distribution of glycemic measurements in fasting children

Blood glucose values in children undergoing elective procedure under general anaesthesia.

Time frame
Immediately/within five minutes after anesthesia induction
3

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

Time frame
Immediately/within five minutes after anesthesia induction
4

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

Time frame
Immediately/within five minutes after anesthesia induction

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

Evelina London Children's Charity

Collaborator

Nova Biomedical

Collaborator

Kings Health Partners

Collaborator