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How safe is paracetamol for children?


Most parents have given their children paracetamol at one time or another, yet paracetamol overdose is the leading cause of liver failure in children. So how safe is this commonly used medication and when should we give it to children?

By Dr Jocelyn Lowinger
If you have young children, then chances are you have paracetamol in your medicine cupboard and use it to treat some of the many ailments that are part of childhood.

In fact, few parents wouldn't have used this common medication to bring down a child's fever or ease the discomfort of teething pain, colds and flus, or ear aches.

Yet while paracetamol is a very safe medicine when it is given correctly, if children are given too much it can be dangerous and in very rare cases deadly.

A recent study found paracetamol to be the leading cause of liver failure in children in Australia and New Zealand. The researchers identified 54 cases of liver failure in two children's hospitals between 2002 and 2012, 14 of these cases were related to paracetamol overdose, and 12 were in children under five years old. While the overall number of cases of children that experienced liver damage was low, the researchers are calling for a review of the safety practices around paracetamol use.

Associate Professor Madlen Gazarian, a consultant in Paediatric Clinical Pharmacology & Therapeutics and an Honorary Associate Professor at the University of NSW, has extensively researched the appropriate and safe use of medicines in children, including use of paracetamol.

She says accidental harm from paracetamol is generally the result of:
  • a single large overdose
  • a number of doses that are slightly too high.
"The first thing parents and carers need to know is whether and when it is appropriate to use paracetamol, including when they should seek medical advice for an unwell child."

In her view, people need to understand it isn't always necessary to give paracetamol to young children when they have fevers, which are often caused by common viral illnesses.

As well, she says parents and carers also need to know how to use paracetamol safely – including making sure the dose, formulation and strength are appropriate, how long to use it for and how to make sure storage and administration are safe.

She answers some common questions parents have when it comes to treating fever.

When should I take my child to the doctor?

Take your child to the doctor if they have a fever (eg temperature greater than 38.5oC, under the armpit) and:
  • they look very sick.
  • they are less than 6 months old.
  • you have been giving paracetamol every 4 to 6 hours for fever for 24 to 48 hours and they still have a fever.
  • they have symptoms like:
    • a stiff neck or light hurting their eyes
    • vomiting and refusing to drink much
    • a rash
    • being more sleepy than usual
    • having problems with breathing
    • pain.
  • you are otherwise worried about them.
See your doctor if your child becomes unwell while taking paracetamol.


Can a fever harm my child?

"Parents and carers can be reassured that fever, by itself, is not harmful to a generally healthy child," Gazarian says.

Fever is a common symptom of many childhood illnesses and is part of the body's normal response to help fight off an infection. But that doesn't mean you can ignore a fever altogether, as it can be a sign of an illness that's serious if not treated. So it's important to watch for any additional signs and know when to see the doctor.

While many parents worry their child may get fever fits (febrile convulsions) if their temperature gets too high, there is no evidence that bringing down a child's temperature can prevent them, Gazarian says.


When should I use a medicine to treat fever?

Treating fever is not about lowering the number on the thermometer, Gazarian says.

"The aim of any treatment for fever is to improve the child's overall comfort, rather than trying to just bring the temperature down to normal."

"Most children tolerate low-grade fever (up to 38.5°C) well and usually don't need any medicine to treat it".

"Some children with a viral illness might have a temperature of 39°C and are running around happy as Larry. They don't need anything given to them," she says.

Gazarian recommends paracetamol for children who have a fever over 38.5°C (measured via the armpit) and if they are uncomfortable, such as if they have a headache or feel miserable.


How does ibuprofen compare to paracetamol for fever?

While paracetamol and ibuprofen are equally good at reducing a child's temperature, Gazarian says, "paracetamol is the first choice".

That's because paracetamol has been used for a lot longer and there's better data on how effective it is; it's still not clear if ibuprofen works as well. It's also not yet known if there are any differences in the overall harm to children.

As well, the potential harms of using ibuprofen to treat fever are different from those of paracetamol, Gazarian says.

While paracetamol is known to cause liver damage if you give too much of it, ibuprofen (like other non-steroidal anti-inflammatory drugs) can cause gut problems and kidney damage in some children, even when it is given at the recommended dose.

"Dehydrated children or those with complex medical illnesses may be at greater risk of kidney problems with ibuprofen," she says.

Do not give:
  • ibuprofen to children under 6 months of age,
  • paracetamol to children under 3 months of age.
While some medical professionals recommend alternating paracetamol and ibuprofen when treating a fever, Gazarian does not agree. It's not known if this is helpful to children and it may cause confusion and mistakes in giving children accurate doses.
What else can I do to help treat a fever?

If your child has a fever, encourage them to rest. Dress them lightly, but make sure they aren't cold or shivering.

Give them plenty of clear fluids so they don't get dehydrated. Children younger than 6 months can have extra cooled pre-boiled water, breast milk or formula.



How do I get it right when giving paracetamol to my child?

Gazarian recommends parents and carers consider the following before giving paracetamol to their children:

When should I consider using paracetamol?
  • Only consider using paracetamol if your child has pain or they have a temperature above 38.5°C (measured via the armpit) and they are uncomfortable. Always use a thermometer to decide if there is a fever.
  • If your child takes other medications or has other medical illnesses, check with your doctor to see if this affects paracetamol use.
  • Do NOT use paracetamol to "settle" a child at night.
How do I use paracetamol correctly?

1. Choose the right product for the age of your child
  • Choose a strength and formulation that is appropriate for the age of your child. Ask your doctor or pharmacist if you are not sure.
  • Do NOT use adult strength preparations for young children.
2. Choose the right dose
  • Follow the dosing instructions on the medicine label (or your doctor's advice).
  • If your child is large or small for their age check with your doctor as they may need a different dose.
  • Do NOT give more than the maximum adult dose of 4 grams of paracetamol a day regardless of their weight. Some older or heavier children can have a weight-based dose that is higher than the recommended maximum adult dose of 4 grams per day. If this happens check with your doctor about the right dose to give your child.
3. Measure the dose correctly
  • Use the supplied measuring tool (eg syringe) to measure the dose and follow the instructions to make sure you are using it properly.
4. Give the dose at appropriate intervals
  • Give every 4-6 hours but do NOT give more often than 4 times a day.
  • Do NOT wake a child to give them paracetamol.
5. Take care with other medicines
  • Make sure you don't accidentally double up on paracetamol contained in any other medicines. Always read the label to see if your child's medicine contains paracetamol, so that you do not give too much paracetamol by mistake.
  • Do not alternate use of ibuprofen and paracetamol.
6. Avoid confusion
  • Keep a written record of how much paracetamol you have given and when you gave it – this can help you remember times and doses and is useful for other people who may be caring for your child.
7. Store medicines safely
  • Store paracetamol out of reach of children in a child-proof cabinet.
8. Keep an eye on your child and see your doctor if:
  • You have been using paracetamol for longer than 48 hours.
  • They get worse.
  • You think you have given too much paracetamol.
  • You are otherwise worried.
If you think you have given too much paracetamol then either:
  • Contact the Poisons Information Centre (Telephone 13 11 26) OR
  • Contact your doctor OR
  • Go to the nearest emergency department.
Do this even if your child does not seem sick.






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