Evidence map›Paper›PMID 18765450›Full record

Trial reportBMJ (Clinical research ed.)2008

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

Alastair D Hay, Céire Costelloe, Niamh M Redmond, Alan A Montgomery, Margaret Fletcher, Sandra Hollinghurst, Tim J Peters

Erratum issued Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02294071 (Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children), which is not on this map. Cited by 42 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 6 pooled it
8.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02294071 phase4unknown statusnot on this mapstarted 2014, after this paper: background citation

Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2014Enrolled120ConditionsFeverArmsIbuprofen, Acetaminophen
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 6 syntheses or guidelines pooled it, 165 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Alastair D HayAcademic Unit of Primary Health Care, NIHR National School for Primary Care Research, Department of Community Based Medicine, University of Bristol, Bristol BS8 2AA. alastair.hay@bristol.ac.uk
Céire Costelloe
Niamh M Redmond
Alan A Montgomery
Margaret Fletcher
Sandra Hollinghurst
Tim J Peters
NIHR School for Primary Care ResearchUniversity of Bristol · GBPrimary Health Care · QAUniversity of the West of England · GB

Funding

Department of Health 03/09/01
6 · The paper itself

Abstract

objectiveTo 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.

designIndividually randomised, blinded, three arm trial.

settingPrimary care and households in England.

participantsChildren aged between 6 months and 6 years with axillary temperatures of at least 37.8 degrees C and up to 41.0 degrees C.

interventionAdvice on physical measures to reduce temperature and the provision of, and advice to give, paracetamol plus ibuprofen, paracetamol alone, or ibuprofen alone.

main outcome measuresPrimary 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.

resultsOn 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.

conclusionParents, 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 registrationCurrent Controlled Trials ISRCTN26362730.

Indexed as

AcetaminophenAnalgesics, Non-NarcoticBody TemperatureChildChild, PreschoolDrug Therapy, CombinationFeverHumansIbuprofenInfantTreatment OutcomeAcetaminophenAnalgesics, Non-NarcoticIbuprofen

Identifiers

PMID18765450
PMCPMC2528896
OpenAlexW2022499157

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.