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Comparison of multidose ibuprofen and acetaminophen therapy in febrile children
P D Walson1, G Galletta, F Chomilo
1Department of Pediatrics, Ohio State University.
Insights
Ibuprofen (10 mg/kg) and acetaminophen (15 mg/kg) equally reduced fever in children. Both medications were well-tolerated, with no significant differences in adverse effects observed between the two highest doses.
Area of Science:
- Pediatrics
- Pharmacology
- Clinical Medicine
Background:
- Fever is a common symptom in children, often managed with antipyretic medications.
- Ibuprofen and acetaminophen are widely used antipyretics, but optimal dosing and comparative efficacy require ongoing research.
Purpose of the Study:
- To compare the efficacy and safety of different doses of ibuprofen liquid and acetaminophen elixir in reducing fever in children.
- To determine if ibuprofen and acetaminophen demonstrate equivalent fever reduction and adverse effect profiles.
Main Methods:
- A randomized, double-blind, multidose, parallel-group clinical trial was conducted.
- 64 febrile children (aged 6 months to 11 years) received ibuprofen (2.5, 5, or 10 mg/kg) or acetaminophen (15 mg/kg) every 6 hours for 24-48 hours.
- Temperature reduction and adverse effects were monitored throughout the study.
Main Results:
- Both 10 mg/kg ibuprofen and 15 mg/kg acetaminophen were effective and well-tolerated in reducing fever.
- Initial fever reduction was similar between 10 mg/kg ibuprofen and 15 mg/kg acetaminophen.
- After the second dose, no statistically significant differences in temperature response were observed among the treatment groups.
- Hypothermia occurred in three children receiving acetaminophen; one child receiving 2.5 mg/kg ibuprofen experienced gastrointestinal distress.
Conclusions:
- 10 mg/kg ibuprofen and 15 mg/kg acetaminophen administered every 6 hours are equally effective and well-tolerated for fever reduction in children.
- Lower doses of ibuprofen (2.5 and 5 mg/kg) were less effective initially but comparable to higher doses thereafter.
- Further studies are needed, but these findings support the use of 10 mg/kg ibuprofen and 15 mg/kg acetaminophen as effective fever reducers.
Objective:
To determine whether febrile children receiving 2.5-, 5-, or 10-mg/kg ibuprofen therapy via a liquid or 15-mg/kg acetaminophen therapy via an elixir every 6 hours for 24 to 48 hours show equivalent fever reduction or suffer adverse effects of the drug administered.
Design:
Randomized, double-blind, multidose, parallel-group, variable-duration (24 to 48 hours) clinical trial.
Setting:
The academically affiliated Children's Hospital in Columbus, Ohio.
Participants:
64 febrile (defined as oral or rectal temperature of 39 degrees C to 40.5 degrees C) but otherwise healthy children aged 6 months to 11 years 7 months randomly assigned to one of the four drug regimens.
Interventions:
Treatment with either ibuprofen or acetaminophen as described above. Administration of antibiotics or intravenous fluids was allowed only after at least 24 hours of treatment with the assigned drug.
Measurements/Main Results:
In 61 of the 64 evaluable patients, treatments were effective and well tolerated during the entire study. While the rates of temperature reduction and maximal reduction of fever after administration of the initial dose were equal for patients receiving 10-mg/kg ibuprofen therapy and 15-mg/kg acetaminophen therapy, and both regimens were more effective than smaller doses of ibuprofen in reducing fever, after the second dose (and continuing to the end of the study) there were no statistically significant differences in temperature response among the treatment groups. Six children were withdrawn from the study, two because of dosing errors, three because of hypothermia (temperature of less than 35.6 degrees C; all three patients were in the acetaminophen group), and one because of gastrointestinal distress (this child was in the group receiving 2.5-mg/kg ibuprofen therapy). No other significant symptoms or adverse laboratory or physical findings were noted. While further confirmatory studies are needed, ibuprofen liquid (10 mg/kg) and acetaminophen elixir (15 mg/kg) administered every 6 hours for 24 to 48 hours appeared to be most effective in reducing fever. These two regimens were equally effective and equally tolerated in febrile children. Lower ibuprofen doses (2.5 and 5 mg/kg) were less effective than acetaminophen and 10-mg/kg ibuprofen therapy after the initial dose but were at least equally effective as these two higher-dose regimens thereafter.