Ibuprofen and paracetamol in combination and separately for fever in pre-school children presenting to primary care: a randomised controlled trial.
| ISRCTN | ISRCTN26362730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26362730 |
| Secondary identifying numbers | HTA 03/09/01 |
- Submission date
- 24/06/2004
- Registration date
- 24/06/2004
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Alastair Hay
Scientific
Scientific
Academic Unit of Primary Health Care
Department of Community Based Medicine
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
| Phone | +44 (0)117 954 6632/6694 |
|---|---|
| alastair.hay@bristol.ac.uk |
Study information
| Study design | Three-arm, placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ibuprofen. paracetamol |
| Primary outcome measure | 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 study start date | 01/12/2004 |
| Overall study end date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 831 |
| Participant inclusion criteria | Previously well children aged >6 months and <5 years presenting to primary care with a temperature at least 38°C. |
| 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
- England
- United Kingdom
Study participating centre
Academic Unit of Primary Health Care
Bristol
BS6 6JL
United Kingdom
BS6 6JL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/09/2008 | Yes | No | |
| Other publications | economic evaluation | 09/09/2008 | Yes | No | |
| Other publications | health technology assessment | 01/05/2009 | Yes | No | |
| Other publications | 11/08/2009 | Yes | No |
