Adding a Second Drug for Febrile Children Treated With Acetaminophen
Information source: Assaf-Harofeh Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever
Intervention: Ibuprofen, acetaminophen (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Assaf-Harofeh Medical Center Official(s) and/or principal investigator(s):
Eran Kozer, Principal Investigator, Affiliation: Assaf-Harofeh Medical Center
Overall contact:
Eran Kozer, MD, Phone: 972 8 9779916, Email: erank@asaf.health.gov.il
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.
Clinical Details
Official title: Adding a Second Drug for Febrile Children Treated With Acetaminophen
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.
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
Intervention:
Patients will be recruited in the ED and pediatric ward at Assaf Harofeh Medical Center.
Legal guardians of eligible patients will be approached for consent. After obtaining
informed consent a detailed history regarding the way fever was managed during the current
illness will be collected (appendix 1). Patients will be randomized in a ratio of 2: 1 (by a
computer generated list of random numbers) into one of two groups. Group A will be treated
with oral suspension of ibuprofen 10mg/kg (if the patient received acetaminophen at home)
or oral suspension of acetaminophen 15 mg/kg (if treated previously with ibuprofen). The
second group will be treated with the same amount of oral placebo suspension. The parents
and the physician will be blinded to the treatment given. Body departure will be recoded at
base line and at 15, 30, 60, 90, 120, 180 minutes after the drug administration. Blood
sample for serum concentrations of acetaminophen or/and ibuprofen will be taken at the time
of routine blood sampling according to the attending physician decision. Serum
concentrations will not be measured if the attending physician decides that blood tests are
not indicated.
Primary outcome:
· Maximal change in temperature during the 3-hour period after enrollment.
Secondary endpoints:
- Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at the
end of the study (3 hours).
- Decrement in fever at each time point, and the area under the temperature (versus time)
curve for each group, calculated using the trapezoidal method. Continuous outcomes
- Proportion of patients with temperature < 38 at the end of the study (3 hours).
Eligibility
Minimum age: 6 Months.
Maximum age: 4 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Eran Kozer, MD, Phone: 972 8 9779916, Email: erank@asaf.health.gov.il
Pediatric Emergency Medicine Service, Assaf Harofeh Medical Center, Zerifin 70300, Israel; Recruiting
Eran Kozer, MD, Principal Investigator
Additional Information
Starting date: September 2005
Ending date: December 2008
Last updated: October 30, 2007
|
