Ibuprofen and paracetamol in combination and separately for fever in pre-school children presenting to primary care: a randomised controlled trial. - PITCH

Phase 1

• Conditions: Fever of early childhood

• Registration Number: EUCTR2004-000160-28-GB
• Lead Sponsor: Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-11
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 831

Inclusion Criteria

Previously well children aged between 6 months and five years with a nurse measured temperature of 38°C (100°F) or more and less than 40°C (104°F) presenting for the first (for that episode of fever) time to primary care.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Children who have previously participated in the trial, those with illnesses requiring hospital admission, vomiting within 12 hours, dehydration, known previous epilepsy or other chronic neurological disease, known previous peptic ulceration or bleeding, pulmonary (other than asthma), liver, renal, cardiac disease or skin conditions precluding the use of adhesive tape. We will exclude children with known allergy or intolerance to the study medicines or known contra-indications or cautions as identifed by the British National Formulary. We will also exclude those attending at inconvenient times (after 9pm) or whose parents cannot read/write English.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This trial will establish whether the 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.;Secondary Objective: (a) 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. (b) To perform an economic evaluation from the perspective of the NHS comparing the cost and benefits of each treatment and (c) To describe the natural history of fever.;Primary end point(s): (i) Fever clearance in the first four hours (thermometry every 5 minutes using a data logger)<br>(ii) 48-hour discomfort score (parent symptom score)