Fever Clinical Trial
Official title:
Adding a Second Drug for Febrile Children Treated With Acetaminophen
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 4 Years |
Eligibility |
Inclusion Criteria: - Age: 6 mo- 4 years - Rectal temperature > 38.5 - Received 10-15 mg/kg of acetaminophen or 5-10 mg/kg of ibuprofen 1.5 - 3.5 hours before admission to the Exclusion Criteria: - Received more than 75 mg acetaminophen in the last 24 hours - Unable to take oral medications - Hypersensitivity to acetaminophen or ibuprofen - Varicella - Renal failure - Liver disease - Rectal temperature can't be measured (due to anatomical or medical problem) - Received both Ibuprofen and acetaminophen in the last 6 hours - Informed consent could not be granted |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Pediatric Emergency Medicine Service, Assaf Harofeh Medical Center | Zerifin |
Lead Sponsor | Collaborator |
---|---|
Assaf-Harofeh Medical Center |
Israel,
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