A randomised controlled trial of the combined use of paracetamol and ibuprofen to treat febrile children - Treatment of childhood fevers

Phase 1

• Conditions: Fevers in childhood not asscoaited with severe disease in the immunocompenetent or fever in the immunocompromised host.

• Registration Number: EUCTR2004-002137-39-GB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 120

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the efficacy of a combined dose of ibuprofen and paracetamol at reducing fever in children;Secondary Objective: If discharged from hospital, time spent in the department;Primary end point(s): ·The child’s temperature one hour after study antipyretics.