Acetaminophen controlled-release sprinkles versus acetaminophen immediate-release elixir in febrile children

Area of Science:

• Pediatrics
• Pharmacology
• Clinical Medicine

Background:

• Current acetaminophen (APAP) formulations for pediatric fever require frequent dosing (up to five times daily), potentially leading to poor compliance and breakthrough fever.
• The need for improved pediatric antipyretic options with better compliance and sustained efficacy is critical for managing febrile children.

Purpose of the Study:

• To compare the efficacy and safety of a single dose of controlled-release acetaminophen (APAP-CR) versus multiple doses of immediate-release acetaminophen (APAP-IR) in reducing fever in children.

Main Methods:

• A double-blind, double-dummy, randomized, multicenter study involving 112 children aged 2-11 years with fever.
• Participants received either one dose of APAP-CR sprinkles or two doses of APAP-IR elixir over 8 hours.
• Temperature reductions were measured, and pharmacokinetic/pharmacodynamic modeling was performed.

Main Results:

• APAP-CR demonstrated significantly greater aural temperature reductions at 4 and 5 hours compared to APAP-IR.
• The overall 8-hour area under the curve (AUC) of temperature reduction was not significantly different between APAP-CR and APAP-IR.
• Prior or concurrent antibiotic use did not impact the antipyretic effect.

Conclusions:

• A single dose of APAP-CR provides comparable 8-hour antipyretic efficacy to two doses of APAP-IR in children aged 2-11 years.
• APAP-CR's prolonged effect and reduced dosing frequency may improve compliance and management of fever in children.