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

BMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a1490 (Published 09 September 2008) Cite this as: BMJ 2008;337:a1490
  1. Sandra Hollinghurst, senior lecturer in health economics1,
  2. Niamh Redmond, trial coordinator1,
  3. Céire Costelloe, trial coordinator1,
  4. Alan Montgomery, senior lecturer in primary care research1,
  5. Margaret Fletcher, reader in children’s nursing2,
  6. Tim J Peters, professor of primary care health services research1,
  7. Alastair D Hay, consultant senior lecturer in primary health care1
  1. 1Academic Unit of Primary Health Care, NIHR National School for Primary Care Research, Department of Community Based Medicine, University of Bristol, Bristol BS8 2AA
  2. 2Faculty of Health and Social Care, University of the West of England, Bristol BS16 1QY
  1. Correspondence to: S Hollinghurst s.p.hollinghurst{at}bristol.ac.uk
  • Accepted 21 August 2008

Abstract

Objective To estimate the cost to the NHS and to parents and carers of treating febrile preschool children with paracetamol, ibuprofen, or both, and to compare these costs with the benefits of each treatment regimen.

Design Cost consequences analysis and cost effectiveness analysis conducted as part of a three arm, randomised controlled trial.

Participants Children between the ages of 6 months and 6 years recruited from primary care and the community with axillary temperatures ≥37.8°C and ≤41°C.

Interventions Paracetamol, ibuprofen, or both drugs.

Main outcome measures Costs to the NHS and to parents and carers. Cost consequences analysis at 48 hours and 5 days comparing cost with children’s temperature, discomfort, activity, appetite, and sleep; cost effectiveness analysis at 48 hours comparing cost with percentage of children “recovered.”

Results Difficulties in recruiting children to the trial lowered the precision of the estimates of cost and some outcomes. At 48 hours, cost to the NHS was £11.33 for paracetamol, £8.49 for ibuprofen, and £8.16 for both drugs. By day 5 these costs rose to £19.63, £18.36, and £13.92 respectively. For parents and carers, the 48 hour costs were £23.86 for paracetamol, £20.60 for ibuprofen, and £25.07 for both, and the day 5 costs were £26.35, £29.90, and £24.02 respectively. Outcomes measured at 48 hours and 5 days were inconclusive because of lack of power; the cost effectiveness analysis at 48 hours provided little evidence that one treatment choice was significantly more cost effective than another. At 4 hours ibuprofen and the combined treatment were superior to paracetamol in terms of the trial primary outcome of time without fever; at 24 hours the combined treatment performed best on this outcome.

Conclusions There is no strong evidence of a difference in cost between the treatments, but clinical and cost data together indicate that using both drugs together may be most cost effective over the course of the illness. This treatment option performs best and is no more expensive because of less use of healthcare resources, resulting in lower costs to the NHS and to parents.

Footnotes

  • We thank the Avon, Gloucestershire and Wiltshire NHS Direct, the Bristol general practices, the South Bristol Walk-In Centre, the Bristol Royal Hospital for Children’s Emergency Department, and the children and parents whose participation made this study possible. We thank the South West Medicines for Children Local Research Network (MCRN); the research nurse team W Horseman, J Farrimond, R Powell, S Shatford, P Richards, and MCRN nurse V Payne; W Patterson (trial coordinator); S Doohan and S Burke (project administrators); K Schroeder, M Weiss, and A Emond (co-applicants); and K Pitcher (data entry/quality). We thank the Trial Steering Committee (AL Kinmonth, C Butler, J Peacock, M Blythe, and P Denyer) and Data Monitoring and Safety Committee (R Bragonier, S Kerry, and J Chudleigh) for their support.

  • Contributors: ADH had the original idea for the study. ADH, TJP, AM, and MF designed the study and obtained funding. NR and CC coordinated the trial on a day to day basis and managed the data. The analysis was carried out by SH, with all authors contributing to the interpretation of the results. SH wrote the paper, with comments and contributions from all authors, who all approved the final version. SH is guarantor for the paper.

  • Funding: The study was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme (project number 03/09/01). The final study design, data collection and analysis, interpretation of results and paper writing was the sole responsibility of the authors. For the duration of the trial, AH held a postdoctoral award from the National Coordinating Centre for Research Capacity Development (NCCRCD), Department of Health. The views and opinions expressed in this paper do not necessarily reflect those of the NIHR HTA, NCCRCD, or Department of Health. The active drugs and matched placebos were purchased from Pfizer and DHP Investigational Medicinal Products respectively. Neither had any other role in the design, conduct, analysis, or reporting of the trial.

  • Competing interests: None declared.

  • Ethical approval: The study was approved by the Bath Research Ethics Committee, UK (reference number 04/Q2001/197).

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