Condition category
Signs and Symptoms
Date applied
24/06/2004
Date assigned
24/06/2004
Last edited
25/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alastair Hay

ORCID ID

Contact details

Academic Unit of Primary Health Care
Department of Community Based Medicine
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
+44 (0)117 954 6632/6694
alastair.hay@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 03/09/01

Study information

Scientific title

Acronym

PITCH (Paracetamol and Ibuprofen for the Treatment of fever in CHildhood)

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.

Ethics approval

Not provided at time of registration

Study design

Three-arm, placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Fever

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Ibuprofen. paracetamol

Primary outcome measures

1. Fever clearance in the first four hours (data logger)
2. 48-hour discomfort score (parent symptom score)

Secondary outcome measures

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.

Overall trial start date

01/12/2004

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Previously well children aged >6 months and <5 years presenting to primary care with a temperature at least 38°C.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

831

Participant exclusion criteria

Excluding children with epilepsy or known contraindications to the study medicines.

Recruitment start date

01/12/2004

Recruitment end date

30/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Primary Health Care
Bristol
BS6 6JL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Hay AD, Costelloe C, Redmond NM, Montgomery AA, Fletcher M, Hollinghurst S, Peters TJ, Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial., BMJ, 2008, 337, a1302.

  2. Economic evaluation

    Hollinghurst S, Redmond N, Costelloe C, Montgomery A, Fletcher M, Peters TJ, Hay AD, Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic evaluation of a randomised controlled trial., BMJ, 2008, 337, a1490.

  3. Health technology assessment

    Hay AD, Redmond NM, Costelloe C, Montgomery AA, Fletcher M, Hollinghurst S, Peters TJ, Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial., Health Technol Assess, 2009, 13, 27, iii-iv, ix-x, 1-163, doi: 10.3310/hta13270.

Additional files

Editorial Notes