National Institute for Health and Clinical Excellence (NICE)による昨年出されたガイドラインでは、発熱のために具合が悪い子どもに対してイブプロフェンまたはアセトアミノフェンのどちらかを使用できるとしている。十分なエビデンスがないので２種類を同時に使用したり交互に使用したりすべきでない。
Page last updated at 23:00 GMT, Tuesday, 2 September 2008 00:00 UK
'Ibuprofen best' for child fevers
Ibuprofen is better at alleviating childhood fever than paracetamol and should be the drug of first choice, say UK researchers.
The Bristol-based trial involving 156 children aged between six months and six years showed ibuprofen reduced temperature faster than paracetamol.
The British Medical Journal work also says alternating the two drugs could help, which some GPs already recommend.
But experts advised against this, in line with official guidance.
The concern is the relative ease with which children could receive an overdose.
Fever is very common in young children, affecting seven in every 10 preschool children each year.
Parents wanting to use medicines to treat young, unwell children with fever should be advised to use ibuprofen first
Lead researcher Dr Alastair Hay
It can be miserable for the child and cause anxiety for parents. Most fevers will settle by themselves but a few are caused by serious infections such as pneumonia.
Guidelines published last year by the National Institute for Health and Clinical Excellence (NICE) say either ibuprofen or paracetamol can be used for children unwell or distressed with fever.
But they say that, due to the lack of evidence, the two drugs should not be given together or alternated.
The researchers from the University of Bristol and the University of the West of England, recruited children who had a temperature between 37.8 and 41 degrees centigrade, due to an illness that could be managed at home.
Children were randomised to receive either paracetamol plus ibuprofen, just paracetamol, or just ibuprofen.
The medicines were given over a 48-hour period, with the group of children on both paracetamol and ibuprofen receiving them as separate doses.
This group received one dose of paracetamol every four to six hours (maximum of four doses in 24 hours) and then one dose of ibuprofen every six to eight hours (maximum of three doses in 24 hours).
A normal temperature is between 36-36.8C (96.8-98.24F)
In children, any temperature of 38C (100.4F) or above is considered high and is called a fever
To find out if your child has a fever, place a thermometer under your child's armpit or use a special ear thermometer
The children's condition was followed up at 24 hours, 48 hours and at day five.
The researchers found that in the first four hours children given both medicines spent 55 minutes less time with fever compared to those given paracetamol alone.
But giving two medicines was not markedly better than just giving ibuprofen.
However, over a 24 hour period, children given both medicines experienced 4.4 hours less time with fever than those given just paracetamol, and 2.5 hours less time with fever than those just given ibuprofen.
Dr Alastair Hay, consultant senior lecturer in primary health care at the University of Bristol, who led the study, said: "Doctors, nurses, pharmacists and parents wanting to use medicines to treat young, unwell children with fever should be advised to use ibuprofen first.
"If more sustained symptom control over a 24-hour period is wanted, giving both medicines alternately is better than giving one on its own.
"However, parents should keep a careful record of when doses are given to avoid accidentally giving too much."
We believe parents should keep it simple. We do not see at this moment any need to change the advice
Professor Steve Fields, chairman of the Royal College of General Practitioners
He said he thought it would be appropriate for NICE to review its guidance in light of the new study, saying the current guidance was too cautious.
In an accompanying editorial in the BMJ, Dr Anthony Harnden from the University of Oxford, warned of the relative ease with which children could receive an overdose.
He said that a "more complicated alternating regimen of paracetamol and ibuprofen may be less safe than using either drug alone".
A spokeswoman for NICE said the 2007 guidance recommended that more research should be conducted on the effectiveness and safety of alternating doses of paracetamol and ibuprofen in reducing fever in children who remain febrile after the first fever-reducing medicine.
She said: "Any newly published research will need to be thoroughly assessed by independent experts as part of the process of updating clinical guidelines.
"This is essential to ensure that any new evidence is of the highest standards before any potential updates can be made to existing guidance."
Professor Steve Fields, chairman of the Royal College of General Practitioners, advised parents and carers of children with fever to follow the NICE guidance.
"We believe parents should keep it simple. We do not see at this moment any need to change the advice.
"However, this paper does demonstrate that using ibuprofen initially is more effective at reducing temperature and may demonstrate that using both ibuprofen and paracetamol together could have a positive effect."
Published 2 September 2008, doi:10.1136/bmj.a1302
Cite this as: BMJ 2008;337:a1302
Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial
Alastair D Hay, consultant senior lecturer in primary health care1, Céire Costelloe, trial coordinator1, Niamh M Redmond, trial coordinator1, Alan A Montgomery, senior lecturer in primary care research1, Margaret Fletcher, reader in children’s nursing2, Sandra Hollinghurst, senior lecturer in health economics1, Tim J Peters, professor of primary care health services research1
1 Academic Unit of Primary Health Care, NIHR National School for Primary Care Research, Department of Community Based Medicine, University of Bristol, Bristol BS8 2AA, 2 Faculty of Health and Social Care, University of West England, Bristol
Correspondence to: A D Hay email@example.com
Objective To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home.
Design Individually randomised, blinded, three arm trial.
Setting Primary care and households in England.
Participants Children aged between 6 months and 6 years with axillary temperatures of at least 37.8°C and up to 41.0°C.
Intervention Advice on physical measures to reduce temperature and the provision of, and advice to give, paracetamol plus ibuprofen, paracetamol alone, or ibuprofen alone.
Main outcome measures Primary outcomes were the time without fever (<37.2°C) in the first four hours after the first dose was given and the proportion of children reported as being normal on the discomfort scale at 48 hours. Secondary outcomes were time to first occurrence of normal temperature (fever clearance), time without fever over 24 hours, fever associated symptoms, and adverse effects.
Results On an intention to treat basis, paracetamol plus ibuprofen were superior to paracetamol for less time with fever in the first four hours (adjusted difference 55 minutes, 95% confidence interval 33 to 77; P<0.001) and may have been as good as ibuprofen (16 minutes, –7 to 39; P=0.2). For less time with fever over 24 hours, paracetamol plus ibuprofen were superior to paracetamol (4.4 hours, 2.4 to 6.3; P<0.001) and to ibuprofen (2.5 hours, 0.6 to 4.4; P=0.008). Combined therapy cleared fever 23 minutes (2 to 45; P=0.025) faster than paracetamol alone but no faster than ibuprofen alone (–3 minutes, 18 to –24; P=0.8). No benefit was found for discomfort or other symptoms, although power was low for these outcomes. Adverse effects did not differ between groups.
Conclusion Parents, nurses, pharmacists, and doctors wanting to use medicines to supplement physical measures to maximise the time that children spend without fever should use ibuprofen first and consider the relative benefits and risks of using paracetamol plus ibuprofen over 24 hours.
Trial registration Current Controlled Trials ISRCTN26362730 [controlled-trials.com] .
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