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Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial.

Abstract：

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 degrees C and up to 41.0 degrees 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 degrees 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.

journal_name

BMJ

journal_title

BMJ (Clinical research ed.)

authors

Hay AD,Costelloe C,Redmond NM,Montgomery AA,Fletcher M,Hollinghurst S,Peters TJ

doi

10.1136/bmj.a1302

subject

Has Abstract

pub_date

2008-09-02 00:00:00

pages

a1302

eissn

0959-8138

issn

1756-1833

journal_volume

337

pub_type

杂志文章,多中心研究,随机对照试验

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Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial.