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Study design
Design:
randomised controlled trial (Paracetamol plus Ibuprofen for the Treatment of fever in CHildren [PITCH]). Current Controlled Trials ISRCTN26362730.
Allocation:
concealed.*
Blinding:
blinded (patients, parents, research nurses, pharmacy staff, investigators, data analysts, and safety committee).*
Study question
Setting:
35 primary care sites in the area of Bristol, UK.
Patients:
156 children 6 months to 6 years of age (mean age 2 y, 56% boys) who had an axillary temperature of 37.8°C to 41°C and could be managed at home. Exclusion criteria included dehydration and chronic neurological disease.
Interventions:
paracetamol (PCM) (acetaminophen), 15 mg/kg (every 4–6 h, maximum 4 doses/d), plus ibuprofen (IBF), 10 mg/kg (every 6–8 h, maximum 3 doses/d) (n = 52); PCM alone (n = 52); or IBF alone (n = 52) for ⩽48 hours. …
Footnotes
Source of funding: Health Technology Assessment Programme.