- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Anaesthesia and intensive care, Nutrition and dietetics, and Paediatrics and neonatology
Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
Article date: October 2012
Intravenous hypotonic saline (0.18% saline/4% glucose infusion solution) is given to maintain normal fluid and electrolyte requirements, or to replenish substantial deficits or continuing losses.
Following the restart of a public inquiry primarily into the deaths of three children in the UK who died of cerebral oedema secondary to hyponatraemia after administration of intravenous hypotonic saline, the Commission on Human Medicines (CHM) has recently reviewed all data on the benefits and risks of this solution when used in children.
There have been over 50 reported permanent neurological injuries or deaths in children worldwide as a result of iatrogenic hyponatraemia associated with the use of hypotonic intravenous fluids, often in previously healthy children undergoing routine elective surgery. In addition, several published studies and reviews have demonstrated hyponatraemia after administration of hypotonic intravenous fluids such as 0.18% saline/4% glucose1 2 3 4.
On the basis of the evidence from the review, the CHM concluded that the use of 0.18% saline/4% glucose should be contraindicated in all but a limited group of children treated by experts in paediatric specialist settings, such as renal, cardiac, liver, high dependency, and intensive care units.
Product information and packaging for intravenous 0.18% saline/4% glucose solutions is being updated with warnings on the risk of hyponatraemia.
The use of any hypotonic intravenous fluids puts children at a greater risk of developing hyponatraemia
Special care should be taken when giving intravenous infusions to infants and children as they are unable to regulate their fluid and electrolytes as effectively as adults. The tonicity and volume of intravenous solution needs to be carefully selected, based on the child’s individual requirements.
A drop in sodium level is more likely to occur when hypotonic fluids are administered to children around surgery or during treatment of any of the following conditions: pain, anxiety, vomiting, fever, severe infection, low blood volume, breathing difficulties, cerebral infection. Hyponatraemia can cause headaches, seizures, tiredness, unconsciousness, cerebral oedema and may lead to death, and therefore children should be closely monitored while receiving intravenous fluid therapy.
Advice for healthcare professionals:
- Intravenous hypotonic saline (0.18% saline/4% glucose infusion) is now contraindicated in children aged 16 years or less except when initiated and maintained under expert medical supervision in paediatric specialist settings – such as renal, liver, cardiac, high dependency and intensive care units
Remove 0.18% saline/4% glucose intravenous infusions from stock and general use in areas that treat children and ensure that suitable alternatives are available (in line with local guidelines). Restrict availability of 0.18% saline/4% glucose intravenous infusions to critical care and specialist wards – according to National Patient Safety Agency’s Alert 22.
If hypotonic intravenous fluids do need to be prescribed to children (according to the strict conditions above), the child’s individual clinical needs and possibility of increased anti-diuretic hormone secretion should be taken into account – fluid balance, plasma and urinary electrolyte concentrations must be carefully monitored during treatment.
- Acute symptomatic hyponatraemic encephalopathy is a medical emergency. Healthcare professionals should therefore be aware of and take prompt action if children receiving hypotonic intravenous fluids develop the signs and symptoms of hyponatraemia (headache, nausea, seizures, lethargy, coma, cerebral oedema).
MHRA Public Assessment Report: Intravenous 0.18% saline/4% glucose infusion solution and the risk of hyponatraemia in children
National Patient Safety Agency (28th March 2007). Patient Safety Alert – Reducing the risk of hyponatraemia when administering intravenous infusions to children
BMJ E-Learning module: Reducing the risk of hyponatraemia when administering intravenous fluids to children
BNFC section 220.127.116.11: Electrolytes and water
Article citation: Drug Safety Update October 2012, vol 6, issue 3: A2
Playfor et al (2004). Hypotonic intravenous solutions in children. Expert Opin. Drug Saf 3 (1); 67 – 73 ↩
Yung et al (2009). Randomized controlled trial of intravenous maintenance fluids. J Paediatr Child Health 49: 9 – 14 ↩
Kannan et al (2010). Intravenous fluid regimen and hyponatraemia among children: a randomized controlled trial. Paediatr Nephrol 25: 2303 – 2309 ↩
Drysdale et al (2010). The impact of the National Patient Safety Agency intravenous fluid alert on iatrogenic hyponatraemia in children. Eur J Paediatr 169 (7): 813 – 817 ↩