Adding a Second Drug for Febrile Children Treated With Acetaminophen
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 40
- Locations
- 2
Study Overview
Brief 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.
Detailed Description
Methods:
Design: randomized double blind placebo controlled study. Setting: The ED and pediatric ward of a large University affiliated Hospital
Participants:
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 ED.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 4 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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