Related Experiment Videos
Dosing and antipyretic efficacy of oral acetaminophen in children
Anthony R Temple1, Brigham R Temple, Edwin K Kuffner
1McNeil Consumer Healthcare, Fort Washington, Pennsylvania; Department of Pediatrics, University of Utah College of Medicine, Salt Lake City, Utah.
Insights
The 10-15 mg/kg oral dose of acetaminophen is effective for reducing fever in children. Current age and weight-based dosing schedules from 1983 remain appropriate for pediatric use.
Area of Science:
- Pediatric pharmacology
- Clinical pharmacology
- Evidence-based medicine
Background:
- Established 1983 dosing guidelines for pediatric acetaminophen.
- Subsequent studies supported the 10-15 mg/kg dose for children.
- This review critically assesses current pediatric dosing.
Purpose of the Study:
- To evaluate the efficacy and appropriateness of the 10-15 mg/kg oral acetaminophen dose in children.
- To assess current pediatric oral dosing schedules for acetaminophen.
Main Methods:
- Systematic review of published and unpublished pediatric antipyretic trials (1980-2012).
- Inclusion criteria: randomized controlled trials, oral dosing, age <12 years.
- Analysis of data from 13 unpublished and 40 published trials.
Main Results:
- Oral acetaminophen at 10-15 mg/kg demonstrated rapid temperature reduction in children.
- Maximum temperature decrease occurred approximately 3 hours post-administration.
- Mild gastrointestinal events were the most common adverse events.
Conclusions:
- The recommended 10-15 mg/kg oral dose of acetaminophen is supported by current data.
- The 1983 age and weight-based dosing schedules for pediatric acetaminophen remain appropriate.
Background:
A standardized approach to dosing acetaminophen in pediatric populations was published in 1983. That review proposed specific weight-related dosing for infants and children weighing 6 through 95 lb and an age-based schedule for children aged <4 months through 11 years. Subsequent clinical studies evaluating these and alternative doses of acetaminophen supported the recommended 10-15-mg/kg dose.
Objective:
This article reviewed published and unpublished pediatric antipyretic data to provide a critical assessment of the 10-15-mg/kg oral dose and the current pediatric oral dosing schedules for acetaminophen.
Methods:
Published literature and unpublished clinical trials that evaluated the antipyretic efficacy of acetaminophen in children were reviewed. The PubMed database was searched using the term acetaminophen or paracetamol, with study criteria limited to randomized, controlled trials; oral dosing; patient age <12 years; and publication between 1982 and August 2012. All of the sponsor's unpublished antipyretic clinical studies completed between 1980 and August 2012 and involving at least 1 oral-formulation acetaminophen-only treatment arm were identified. Data from published literature containing sufficient detail to verify doses; dosing frequency; and, when necessary, estimates from figures, and from acetaminophen arms of the unpublished studies were analyzed.
Results:
Thirteen unpublished trials enrolled 705 children to receive an oral dose of 10-15 mg/kg of acetaminophen. This dose resulted in a rapid onset of temperature reduction, with a maximum temperature decrement of ~3 hours following administration. Results from 40 published clinical trials in which 2332 children received oral acetaminophen for fever support these findings. The most common adverse events reported in any of the reported studies were gastrointestinal in nature and generally mild in intensity.
Conclusions:
Data support the recommended 10-15-mg/kg oral dose and demonstrate that the age and weight schedules for over-the-counter acetaminophen proposed in 1983 remain appropriate.
Related Concept Videos
01:29Drug Dosing: Infants and Children
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
01:17Pharmacokinetics in Pediatric Patients: Drug Distribution
01:21Factors Affecting Drug Response: Overview