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Clinical Trials/EUCTR2004-002137-39-GB
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.

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

Investigators

Sponsor
Not provided

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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