Actively Recruiting

Age: 1Month - 18Years
All Genders
NCT07259629

Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients

Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2025-12-02

6580

Participants Needed

3

Research Sites

87 weeks

Total Duration

On this page

Sponsors

G

Guy's and St Thomas' NHS Foundation Trust

Lead Sponsor

E

Evelina London Children's Charity

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients

Who Can Participate

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 1 month to 18 years with ASA score 1 to 3 presenting for elective procedures under general anesthesia
  • All elective and day case surgeries included, including those admitted overnight for bowel preparation before colonoscopy
  • Planned expedited cases in ASA 1 or 2 children such as nail bed repairs, lacerations, foreign body removal, and simple fracture manipulation
  • MRI, radiology, and dental cases requiring general anesthesia
Not Eligible

You will not qualify if you...

  • Children younger than 1 month old
  • Procedures done under oral sedation or local anesthesia only
  • Children with ASA status 4 or 5
  • Children with endocrine or metabolic conditions affecting glucose control, including diabetes and metabolic disorders
  • Emergency and oncology procedures
  • Critically ill children requiring anesthetic involvement in emergency or intensive care
  • Children receiving glucose-containing intravenous solutions or total parenteral nutrition before surgery
  • Children on systemic steroid treatments (oral or intravenous) but not those using inhalers or topical steroids

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Royal Devon University Healthcare NHS Foundation Trust

Exeter, Devon, United Kingdom, EX2 5DW

Actively Recruiting

2

Moorfields Eye Hospital

London, United Kingdom, EC1V 2PD

Completed

3

Evelina London Children's Hospital

London, United Kingdom, SE17EH

Actively Recruiting

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Research Team

B

Benjamin Blaise, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients | DecenTrialz