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Clinical Trials/EUCTR2004-000160-28-GB
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

Department of Health0 sites831 target enrollmentFebruary 11, 2005

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.

Registry
who.int
Start Date
February 11, 2005
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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