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Ibuprofen and paracetamol in combination and separately for fever in pre-school children presenting to primary care: a randomised controlled trial.
ISRCTN ISRCTN26362730
DOI 10.1186/ISRCTN26362730
ClinicalTrials.gov identifier
EudraCT number
Public title Ibuprofen and paracetamol in combination and separately for fever in pre-school children presenting to primary care: a randomised controlled trial.
Scientific title
Acronym PITCH (Paracetamol and Ibuprofen for the Treatment of fever in CHildhood)
Serial number at source HTA 03/09/01
Study hypothesis Aim: This trial will establish whether paracetamol and ibuprofen combined confers advantages over either agent alone in the relief of fever and its associated symptoms in pre-school children presenting to primary care.
Objectives:
1. To establish the relative clinical effectiveness of paracetamol alone, ibuprofen alone or paracetamol and ibuprofen for fever clearance in the first four hours post randomisation in children aged between 6 months and 5 years presenting to primary care with fever
2. To assess the relative clinical effectiveness of paracetamol alone, ibuprofen alone or paracetamol and ibuprofen for the relief of fever associated discomfort during the period 24 to 48 hours post randomisation
3. To use qualitative methods to optimise the overall trial process and explore parents' and clinicians' beliefs about the use, effectiveness and side effects of ibuprofen and paracetamol
4. To perform an economic evaluation from the perspective of the NHS
comparing the cost and benefits of each treatment
Design: Three-arm, placebo controlled trial with automated telephone randomisation at the level of the individual.
Recruitment: Research nurses will support recruitment from 20 GP surgeries, three GP cooperatives, one WIC and one Children's Emergency Department in the Bristol area.
Lay summary
Ethics approval Not provided at time of registration
Study design Three-arm, placebo controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Fever
Participants - inclusion criteria Previously well children aged >6 months and <5 years presenting to primary care with a temperature at least 38°C.
Participants - exclusion criteria Excluding children with epilepsy or known contraindications to the study medicines.
Anticipated start date 01/12/2004
Anticipated end date 30/11/2007
Status of trial Completed
Patient information material
Target number of participants 831
Interventions Please note that, as of 14 January 2008, the anticipated start and end dates of this trial have been updated from 1 July 2004 and 31 December 2006 to 1 December 2004 and 30 November 2007, respectively.

Interventions:
Up to 48 hours use of the study medicines, given at doses and times according to the British National Formulary (BNF) or Medicines for Children recommendations. All parents will receive two medicines, of which at least one will be active.
Primary outcome measure(s) 1. Fever clearance in the first four hours (data logger)
2. 48-hour discomfort score (parent symptom score)
Secondary outcome measure(s) We will examine the time under fever threshold first 24 hours, adverse events and departures from protocol, the pattern of discomfort scores between 4 and 48 hours, the number of night-time doses administered, other symptoms and the NHS costs associated with the discomfort scores at 48 hours and 5 days.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18765450
2. 2008 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/18782838
3. 2009 health technology assessment in http://www.ncbi.nlm.nih.gov/pubmed/19454182
4. 2009 correction: BMJ 2009;339:b3295
Contact name Dr  Alastair  Hay
  Address Academic Unit of Primary Health Care
Department of Community Based Medicine
Cotham House
Cotham Hill
  City/town Bristol
  Zip/Postcode BS6 6JL
  Country United Kingdom
  Tel +44 (0)117 954 6632/6694
  Fax +44 (0)117 954 6677
  Email alastair.hay@bristol.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 24/06/2004
Last edited 25/08/2009
Date ISRCTN assigned 24/06/2004
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