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Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients

NCT07259629 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 6580

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Hypoglycemia; Iatrogenic
  • Anesthesia
  • Pediatrics

Sponsors & Collaborators

  • Evelina London Children's Charity

    collaborator UNKNOWN

  • Nova Biomedical

    collaborator INDUSTRY

  • Kings Health Partners

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2026-03-30
Completion
2027-01-12

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07259629 on ClinicalTrials.gov