EUCTR2004-002137-39-GB
Active, not recruiting
Phase 1
A randomised controlled trial of the combined use of paracetamol and ibuprofen to treat febrile children - Treatment of childhood fevers
Not provided0 sites120 target enrollmentFebruary 11, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Fevers in childhood not asscoaited with severe disease in the immunocompenetent or fever in the immunocompromised host.
- Sponsor
- Not provided
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •·Age between 6 months and 16 years old
- •·Attending the Children’s Emergency Department of Bristol Royal Hospital for Children
- •·A fever of 38\.0 oC or above by tympanometric thermometer
- •·Written consent signed
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years)
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years)
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Severe or life threatening infection
- •·Children admitted directly to the resuscitation area by ambulance due to the severity of their condition, or those transferred there following initial clinical assessment.
- •Prior administration of study medication:
- •·Paracetamol administered within the last six hours
- •·Ibuprofen administered within the last six hours
- •Current contraindication to either medicine:
- •·Allergy to either ibuprofen or paracetamol
- •·Haematemesis, haematochezia or melaena
- •·Acute jaundice
- •·Likely dehydration as defined by more than four episodes of diarrhoea or vomiting in the last 24 hours
Outcomes
Primary Outcomes
Not specified
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