EUCTR2004-000160-28-GB
Active, not recruiting
Phase 1
Ibuprofen and paracetamol in combination and separately for fever in pre-school children presenting to primary care: a randomised controlled trial. - PITCH
ConditionsFever of early childhood
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Fever of early childhood
- Sponsor
- Department of Health
- Enrollment
- 831
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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