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COMPLETED
NCT07259629

Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients

Sponsor: Guy's and St Thomas' NHS Foundation Trust

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

1 Month - 18 Years

Study Type

OBSERVATIONAL

Enrollment

2902

Start Date

2025-05-12

Completion Date

2026-05-18

Last Updated

2026-07-22

Healthy Volunteers

Yes

Locations (24)

Royal Devon University Healthcare NHS Foundation Trust

Exeter, Devon, United Kingdom

Royal Aberdeen Infirmary

Aberdeen, United Kingdom

Royal Belfast Hospital for Sick Children

Belfast, United Kingdom

Ulster Hospital

Belfast, United Kingdom

Birmingham Women and Children's Hospital

Birmingham, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Children's Hospital of Wales

Cardiff, United Kingdom

Ninewells Tayside Hospital

Dundee, United Kingdom

Royal Hospital for Sick Children

Edinburgh, United Kingdom

Royal Hospital for Children

Glasgow, United Kingdom

Buckinghamshire Healthcare NHS Foundation Trust

High Wycombe, United Kingdom

Moorfields Eye Hospital

London, United Kingdom

Evelina London Children's Hospital

London, United Kingdom

Chelsea and Westminster Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

Royal London Hospital

London, United Kingdom

St George's Hospital

London, United Kingdom

St Mary's Hospital

London, United Kingdom

James Cook University Hospital

Middlesbrough, United Kingdom

Great Northern Children's Hospital

Newcastle, United Kingdom

Nottingham Children's Hospital

Nottingham, United Kingdom

University hospital of Plymouth

Plymouth, United Kingdom

Salisbury NHS Foundation Trust

Salisbury, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom