Paracetamol is a common analgesic and antipyretic drug for management of fever and mild-to-moderate pain in infants and children, and it is considered as first-line therapy for the treatment of both according to international guidelines and recommendations. The mechanism of action of paracetamol is complex and multifactorial, and several aspects of the pharmacology impact its clinical use, especially in the selection of the correct analgesic and antipyretic dose. A systematic literature search was performed by following procedures for transparent reporting of systematic reviews and meta-analyses. To maximize efficacy and avoid delays in effect, use of the appropriate dose of paracetamol is paramount. Older clinical studies using paracetamol at subtherapeutic doses of ≤10 mg/kg generally show that it is less effective than non-steroidal anti-inflammatory drugs (NSAIDs). However, recent evidence shows that when used at dose of 15 mg/kg for fever and pain management, paracetamol is significantly more effective than placebo, and at least as effective as NSAIDs. Paracetamol 15 mg/kg has a tolerability profile similar to that of placebo and NSAIDs such as ibuprofen and ketoprofen used for short-term treatment of fever. However, when used at repetitive doses for consecutive days, paracetamol shows lower risk of adverse events compared to NSAIDs. Also, unlike NSAIDs, paracetamol is indicated for use in children of all ages. Overall, clinical evidence qualifies paracetamol 15 mg/kg a safe and effective option for treatment of pain and fever in children.
Keywords: Antipyretic; Child; Fever; Pain; Paracetamol; Safety.