New paracetamol dosing guidelines

16 November 2018

First published February 2012

What are the new paracetamol dosing guidelines?

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INTRODUCTION

Paracetamol has a long-standing history of efficacy and safety for the treatment of paediatric pain and fever symptoms. Where indicated it is a first-line option recommended by most healthcare professionals1 for pain and fever in children and infants. 

Today, around 84% of children in the UK receive paracetamol by the age of six months.2 The Medicines and Healthcare products Regulatory Agency (MHRA) has provided an update on the dosing of paracetamol to ensure children get the most effective amount that is suitable for their age,2 All children's pai;acetamol-containing medicines on the market will have the new dosing instructions added to the product information. 

 

Timeline 

July 2011 - New dosing instructions for children's paracetamol-containing medicines was advised

November 2011 - UK Public Assessment Report on children's liquid paracetamol products was issued with the reasons why changes have been made to the dosing instructions

December 2011 - All children's paracetamol containing medicines on the market have, the new dosing instructions added to the product information 

THE NEW PARACETAMOL DOSING GUIDELINES

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for regulating medicines and medical devices in the UK. It continually reviews the safety of medicines and vaccines in the UK, and is responsible for informing healthcare professionals and the public of the latest updates.

In 2011, a review of the dosing recommendation for children's liquid paracetamol medicines was announced. The review aimed to determine whether a more effective and practical paracetamol dosing for home care could be provided to parents and carers based on the child's age.

Following this review, a new dosing regimen was introduced to ensure that children get the most effective therapeutic dose of paracetamol for their age. The updated dosing applies equally to prescribed and over-the-counter paracetamol for children. The British National Formulary for Children (BNFC) will be updated accordingly.3 

The changes made to paediatric paracetamol dosing are not the result of any safety concerns and carers should not be worried that they have done anything wrong.4 The new dosing instructions and advice are presented in the tables below.2

Infant paracetamol suspension (120mg/5ml)

WHY HAS THE GUIDANCE CHANGED?

The overall aim of the changes to the paracetamol dosing guidelines is to ensure that all children receive the optimal dose of paracetamol that is suitable for their age. The change has not been made on the basis of any safety concerns. Paracetamol continues to present a good safety profile and be effective for treating short-term pain and fever in children, when used as recommended.2 

The appropriate dose for a child can be calculated in mg per kg of bodyweight which is standard practice in hospitals in the UK; however, this method of dosing is not a practical solution for parents or carers to manage at home. The previous recommended doses of paracetamol have wider age bands and dose ranges within those bands. As a result, children who are light for their age and are receiving the maximum recommended dose may be receiving an amount per kg of bodyweight that differs from older, heavier children taking the lower recommended dose within that age band. This is not a safety concern for lighter children; rather it means that they may be getting more than they need for a therapeutic result.2

To address this, the paracetamol dosing guidelines for children have been changed. The new dosing regimen matches more closely the amounts based on bodyweight with narrower age bands and a single dosing option per band.2

Parents may be concerned or anxious about these new changes and may seek reassurance from their community practitioners. For this reason it is important that you are up-to-date on the reasons for these changes and ready to provide guidance on the new dosing regimen for children's liquid paracetamol products to help put their minds at rest. 

 

TREATING COMMON CHILDHOOD AILMENTS IN PRACTICE

When their child is unwell, parents want to do all they can to help them feel better. As parents are naturally concerned for the safety of their child, and particularly if they are a first-time parent, their concerns and anxieties should be respected and handled gently and effectively. Community practitioners can be the first point of call for anxious parents; therefore, it is important that you have up-to-date information to hand about the various treatment options, and especially on the new paediatric paracetamol dosing instructions.

Paracetamol is a first-line option recommended by most healthcare professionals1 for the treatment of pain and fever in children. It is indicated for the treatment of mild-to-moderate pain and as an antipyretic in children and infants. It is also indicated for the treatment' of post-immunisation fever in infants from the age of two months.2

Pain and/or fever can be a symptom of many childhood ailments. Pain can result from many kinds of injury or illness. The list below provides an overview for some of the common ailments in childhood that can cause pain and/or fever: 

  • Cough 
  • Cold and flu 
  • Sore throat 
  • Earache 
  • Eye infection 
  • Post-immunisation fever Teething 
  • Chickenpox. 

PICKING UP ON PAIN WHEN A CHILD CAN'T TELL YOU

Fever can be measured and observed but small children can't tell you when they are in pain. If parents pay attention to changes in their baby's or toddler's behaviour, it can help them discover if their child is in pain. In children over 3 years of age, using face scales can help parents find out the severity of their pain. 

IDENTIFYING FEVER IN CHILDREN

It is often difficult to identify the cause of fever in young children and, therefore, as a result it can be a diagnostic challenge for healthcare professionals. In the majority of cases, a self-limiting viral infection is the cause of the illness. However, fever may also be the presenting feature of serious bacterial infections such as pneumonia or meningitis. Even despite careful assessment, a significant number of children with fever have no obvious cause for it. These children with fever but without any apparent source are of particular concern because it is especially difficult to distinguish between simple viral illnesses and life-threatening bacterial infections in this group.6

Several definitions of fever have been used in scientific literature. The Clinical Guideline on Feverish Illness in Children defines a fever as 'an elevation of body temperature above the normal daily variation'.This can often be hard to define, as normal temperature varies depending on the individual, how the temperature is measured, the body site where temperature is measured and the time of day. Normal body temperature is usually between 36°C and 36.8°C. It is generally agreed that a child with a temperature more than 38°C has a fever.7

TIPS ON HOW TO DETECT FEVER IN CHILDREN

  • Oral and rectal temperature measurements should not be used routinely to measure the body temperature of children aged 0-5 years
  • In infants under the age of 4 weeks, body temperature should be measured with an electronic thermometer in the axilla 
  • In children aged 4 weeks to 5 years, healthcare professionals should measure body temperature by one of the following methods: 
    - electronic thermometer in the axilla
    - chemical dot thermometer in the axilla
    - Infra-red tympanic thermometer
  • Forehead chemical thermometers are unreliable and should not be used
  • Reported parental perception of a fever should be considered valid and taken seriously by healthcare professionals.6 

The National Institute for Clinical Excellence provides a traffic light system for identifying risk of serious illness in children, shown in Figure 2.

Healthcare professionals should note the following guidance when using the traffic light system: 

  • Children with fever and any of the symptoms or signs in the red column should be recognised as being at high risk
  • Children with fever and any of the symptoms or signs in the amber column and none in the red column should be recognised as being at intermediate risk
  • Children with symptoms and signs in the green column and none in the amber or red column are at low risk 

The management of children with fever should be directed by the level of risk.6

As part of the routine assessment of a child with fever, healthcare professionals should measure and record temperature, heart rate, respiratory rate and capillary refill time. They should also be aware that a raised heart rate can be a sign of serious illness, particularly septic shock, and that a capillary refill time of 3 seconds or longer should be recognised as an intermediate-risk group marker for serious illness. Duration of fever should not be used to predict the likelihood of. serious illness.6 

Body temperature alone should not be used to identify children with serious illness. However, children in the following categories should be recognised as being in a high-risk group for serious illness:6

  • Children younger than 3 months of age with a temperature of 38°C or higher 
  • Children aged 3-6 months with a temperature of 39°C or higher. 

TREATING FEVER IN CHILDREN

In children with fever who appear distressed or unwell the use of antipyretic agents (either paracetamol or ibuprofen) should be considered. In children with fever who are otherwise well, antipyretic agents should not be given routinely with the sole aim of reducing body temperature. Furthermore, paracetamol and ibuprofen should not be administered at the same time to children with fever.6

Healthcare professionals should be aware that antipyretic agents do not prevent febrile convulsions and should not be used specifically for this purpose.

Parents who wish to administer paracetamol to their children with fever and/ or pain should be instructed to follow the new paracetamol dosing guidelines to make sure that they give the most effective therapeutic dose of paracetamol to their child according to their age.

Parents or carers looking after a feverish child at home should be advised:6

  • To offer the child regular fluids (where a baby or child is breastfed, the most appropriate fluid is breast milk) 
  • How to detect signs of dehydration by looking for the following features:
    - sunken fontanelle
    - dry mouth
    - sunken eyes
    - absence of tears
    - poor overall appearance
  • To encourage their child to drink more fluids and consider seeking further advice if they detect signs of dehydration
  • How to identify a non-blanching rash
  • To check their child during the night
  • To keep their child away from nursery or school while the child's fever persists but to notify the school or nursery of the illness. 

FEBRILE SEIZURE

Most febrile seizures occur between 6 months and 5 years of age, and onset is rare after 6 years of age. They arise most commonly from infection or inflammation outside the central nervous system in a child who is otherwise neurologically normal. Seizures arising from fever due to infection in the central nervous system ( e.g. meningitis and encephalitis) are not included in the definition of febrile seizure.

Febrile seizures can be categorised as follows:8

  • Simple febrile seizures are isolated, generalized, tonic-clonic seizures lasting less than 15 minutes, that do not recur within 24 hours or within the same febrile illness 
  • Complex febrile seizures have one or more of the following features: a partial (focal) onset or focal features during the seizure; duration of more than 15 minutes; recurrence within 24 hours, or within the same febrile illness; incomplete recovery within 1 hour 
  • Febrile status epilepticus is a febrile seizure lasting longer than 30 minutes. 

In order to assess a child who has a febrile seizure, from the history and examination, try to determine the cause of the fever; for example, viral illness, otitis media, respiratory infection, urinary tract infection (UTI) or gastroenteritis. The traffic light system may be considered to help identify the likelihood of serious illness. Consider the typical symptoms and signs of specific diseases ( e.g. pneumonia: tachyopnoea, crackles in the chest, nasal flaring, chest indrawing, and cyanosis). An urgent hospital assessment by a paediatrician should be arranged, especially for children with a first seizure.

It is understandable for parents to be concerned if their child has a febrile seizure; therefore, it may help to reassure them that although short-lasting seizures are frightening to watch, they are not harmful to the child, do not cause brain damage and will not cause the child to die. It may also help to advise parents on their future management of a fever and explain that even though controlling fever does not prevent recurrence of a fever, it does make the child more comfortable if they are distressed.8

POST-IMMUNISATION FEVER

Vaccinations, also called immunisations, from two months can provide infants with valuable, long-lasting protection against certain serious infectious diseases. Without them they are much more vulnerable to infections, which can result in handicap or even death. Antibodies from the immune mother are passed to her baby across the placenta during pregnancy giving her baby protection from some infections ( e.g. tetanus and measles). However, this passive immunity only lasts for a few weeks or months. Active immunity can be acquired by natural disease or by vaccination. Vaccines generally provide immunity similar to that provided by the natural infection, but without the risk from the disease or its complications.9 Therefore, it is important to begin the childhood vaccination programme at two months after birth to protect the baby from many serious diseases.

Immunisations produce their protective effect by inducing active immunity and providing immunological memory. Immunological memory enables the immune system to recognise and respond rapidly to exposure to natural infection at a later date and thus to prevent or modify the disease.

For more information about immunisations; how they work, the reasons for immunising children in the community, the diseases immunisations protect against, vaccine safety and supporting parents, you can refer to the Childhood Immunisations supplement published alongside the August 2011 issue of Community Practitioner. Side effects following immunisation are less common than many people think: most are usually mild and resolved quickly.10 Parents may notice some redness or swelling at the site of injection but this usually quickly disappears.9 

If after the immunisation a child is showing pain and/or fever symptoms, an antipyretic drug such as paracetamol can be given. Paracetamol is specifically indicated for the treatment of post­immunisation fever in infants from the age of two months2 and its antipyretic action lasts for up to six hours.11 It is not recommended that antipyretic drugs are given routinely to prevent fever following vaccination as there is some evidence that prophylactic administration of antipyretic drugs around the time of vaccination may lower antibody responses to some vaccines.9

COMMON COLD AND INFLUENZA

The common cold is caused by a wide range of viruses from several different strains and is usually a mild, self-limited upper respiratory tract infection characterised by nasal stuffiness and discharge, sneezing, sore throat and cough. Fever is more common in children and is usually mild (< 39°C). The onset of symptoms is usually relatively rapid with symptoms peaking after 3-5 days. Most symptoms resolve completely after 7-14 days, although a mild cough may persist for longer.12 

It should be explained to parents and carers that comfort measures and rest are the most appropriate management of cold symptoms in children. Antibiotics are ineffective and cause adverse effects. They also increase the risk of bacterial resistance in the community, which may affect treatment of other diseases.12

To alleviate the symptoms of common cold in children, NHS guidance recommends that the following medicines and remedies may help:12 

  • Paracetamol or ibuprofen can be used to ease the pain and lower the child's fever 
  • Nasal saline drops may help relieve nasal congestion. One or 2 drops applied to the nostrils of infants has been reported to help feeding. Sterile sodium chloride 0.9% nasal drops are available on prescription or over the counter 
  • Vapour rubs may soothe respiratory symptoms in infants and small children when applied to the chest and back (avoid application to the nostril area for safety reasons) 
  • For cough in children under 6 years of age only simple, non-pharmacological cough medicines (such as linctus medicines containing glycerol or honey and lemon) should be used. 

Influenza is similar to a cold but the symptoms are more serious. Common symptoms include sore throat, headache, weakness and fatigue, muscle ache, feeling unwell, loss of appetite, insomnia, and a dry, unproductive cough. Fever (typically 38-40°C) tends to be more severe in children. 13

To alleviate the symptoms of influenza in children, parents should be encouraged to give paracetamol or ibuprofen to their children for symptomatic relief. It is also recommended that the child is given adequate amounts of fluids. Children should stay in bed if they are feeling fatigued and be excused from school for about one week. It may help to reassure parents/carers that the worst symptoms of uncomplicated influenza (including fever) resolve after about one week, although other symptoms (such as cough, headache, insomnia, weakness, and loss of appetite) may take longer than two weeks to resolve. Routine follow-up is not necessary, but parents/carers can be advised that urgent medical attention should be sought if the child develops shortness of breath or pleuritic chest pain, or if they start to cough up blood (haemoptysis). A lower threshold for seeking help is needed when caring for a young child or baby with influenza, as children cannot accurately communicate their symptoms.13

Seasonal influenza immunisation is recommended for people at risk of the complications of influenza and is offered free to anyone who is over six months of age and has one of the following I medical conditions:14

  • Chronic (long-term) respiratory disease, such as severe asthma, COPD ( chronic obstructive pulmonary disease) or bronchitis 
  • Chronic heart disease, such as heart failure 
  • Chronic kidney disease 
  • Chronic liver disease, such 
  • as hepatitis 
  • Chronic neurological disease, such as a stroke, TIA ( transient ischemic attack) or post-polio syndrome Diabetes 
  • A weakened immune system due 
  • to conditions such as HIV (human immunodeficiency virus) or treatments that suppress the immune system such as chemotherapy. 

EARACHE

Earache is most commonly caused by infection of the middle ear called acute dtitis media. It most commonly affects young children, and peak incidence is between 6 and 15 months of age. Apart from earache in older children, it can be diagnosed in young babies by noticing that they sometimes pull, touch or rub an affected ear, or have non-specific symptoms (such as fever, irritability, crying, poor feeding, restlessness at night, cough, or rhinorrhoea). Pain and fever associated with acute otitis media can be treated with paracetamol or ibuprofen. Depending on severity or longevity of the condition, the child should be referred to a GP as antibiotics may be required.15 

TEETHING
In general, most infants start teething around 6 months of age but this varies widely. A full set of milk teeth is usually through when the child reaches 2-3 years of age. 17 Symptoms associated with teething generally, start 3-5 days before each tooth eruption and may include increased biting, drooling, gum-rubbing, sucking, irritability, wakefulness, ear-rubbing, facial rash, decreased appetite, disturbed sleep, and (possibly) mild temperature elevation (less than 38°C). Teething symptoms are generally mild and self-limiting however parents 
can consider paracetamol or ibuprofen suspension for relieving the discomfort.

Additionally, self-care measures can be advised to relieve teething symptoms. These include gentle rubbing on the gum with a clean finger or allowing the infant to bite on a clean and cool object. Examples include a chilled teething ring or a cold wet flannel. For children who have been weaned, supervised use of chilled fruit or vegetables (such as bananas or cucumber) can be considered.17 

SUPPORTING PARENTS: A STEP-BY-STEP GUIDE

When a worried parent comes to you for advice, it's not just the facts that you give them that affect how they feel.

Everything about the way you communicate, such as your attitude, tone, patience, body language and ability to listen makes a difference. In general, parents need 30 seconds to settle in at the start of a conversation about their child's health.18 Nine out of 10 parents can't remember what they were told by their health care professional about their child's medicine so talking to parents in a clear and concise way is very important.

The guidance below will help you deliver the best possible conversation.

6 STEPS TO A CONSTRUCTIVE DIALOGUE:18

  1. Stand or sit face-to-face so that you can see and hear each other clearly
  2. Remember the 30 second guide time and start by listening
  3. Ask questions for clarification to help the parent feel confident that they have given you all the essential information
  4. Give feedback that shows you understand the problem or concern as the parent presented it
  5. Provide appropriate advice and suggest next steps
  6. Make sure there is mutual understanding about what happens next - give space for unanswered, awkward or sensitive questions.

OFFERING REASSURANCE TO PARENTS ON THE NEW PARACETAMOL DOSING GUIDELINES

Parents may be concerned in light of the paracetamol dosing changes and they may seek reassurance and guidance from their community practitioner. 

It is important that the changes are explained calmly and carefully to help allay any concerns that they may have.

The key things to communicate to parents or carers when discussing the new paracetamol dosing regimen are:2

  • Always follow the dosing instructions on the product packaging and on the leaflet in the box. 
  • Use the special spoon or syringesupplied with the product pack. The dosing device that is supplied with the liquid paracetamol product should always be used to ensure that the medicine is measured accurately. It is important that parents or carers do not use any other spoon or device to measure the product.
  • Ask a healthcare professional for further advice if needed. 

FREQUENTLY ASKED QUESTIONS

Q. How should parents measure the appropriate dose?

A. Most of the liquid paracetamol medicines for children are supplied with a dosing device such as a measuring spoon. Parents should be reminded to use the dosing device provided with the pack and follow the instructions in the patient leaflet at all times.

Q. Parents are told not to give a paracetamol dose more frequently than 4 hourly and may ask for advice on how to dose if they are administering 7.5ml or 10ml to their child.

A. If the dose appropriate to the age and weight of the child is 7.5 ml, parents can be advised to give 5 ml and 2.5 ml at the same time as that would count as one dose. Similarly, if the dose is 10 ml, they can give two 5 ml spoonfuls at the same time and that counts as one dose.

Q. What should parents do with children's liquid paracetamol that show the previous dosing regimen?

A. Parents can continue to follow the advice on the packaging they have. The previous dosing has been used effectively for many years. The recent changes have been made to more precisely define how much paracetamol should be given to children of different ages, and not because of any safety concerns.

Q. When do the new dosing recommendations for paracetamol take effect?

A. The new dosing recommendations for paracetamol have been in effect since Autumn 2011 and the product information for all children's liquid paracetahiol products has been updated to reflect this.

Q. How effective is paracetamol as an antipyretic?

A. Paracetamol is an effective antipyretic in children and adults at doses between 10-20 mg/kg but the most effective dose range appears
to be 10-15 mg/kg. The amount of temperature reduction achievable with paracetamol depends on the initial temperature - the higher the temperature before paracetamol administration, the greater the amount of reduction seen with treatment.2

FINDING OUT MORE ABOUT THE CHILD PARACETAMOL DOSAGES UPDATE

 

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