drugset / Trial / NCT00389272

Adding a Second Drug for Febrile Children Treated With Acetaminophen

NCT00389272

Unknown 40 enrolled Assaf-Harofeh Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Acetaminophen and ibuprofen are both effective and safe treatments for febrile children. In order to achieve better temperature control and to avoid toxicity it has been suggested to treat febrile children with alternating doses of acetaminophen and ibuprofen. Surveys in the USA and Spain found that this practice is very common. However, The safety and efficacy of such practice was never described. Hypothesis: Children who are still febrile after being treated with acetaminophen or ibuprofen will have greater temperature decrement if treated with another drug (acetaminophen for those treated with ibuprofen and ibuprofen for those treated with acetaminophen) than if treated with placebo.

Timeline

Start
2005-09
Primary completion
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 15 mg/kg Oral
Subject Ibuprofen Small molecule 10 mg/kg Oral

Indications

No indication recorded.