EUCTR2004-002137-39-GBActive, not recruitingPhase 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 enrollmentStarted: February 11, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
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
- •·Cellulitis or other spreading skin infection
- •·Suspected chicken pox
- •·Taking warfarin or heparin or known coagulopathy
- •Chronic illness likely to interfere with drug metabolism
- •·Known chronic kidney disease
- •·Known chronic liver disease
- •Immunosupression
- •·Known primary immunodeficiency or HIV infection
- •·Current treatment with chemotherapy or radiotherapy
- •·Organ or bone marrow transplant recipient
- •·On immunosuppressive therapy either currently or in the last three months (ie daily oral steroids for longer than two weeks, or other immunosuppressive agent)
Investigators
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