Paracetamol efficacy and safety in children: the first 40 years

Abstract

Paracetamol (acetaminophen) has a unique role in children because it is the first-line choice for the treatment of both fever and pain. When used in the recommended doses, it has few side effects and is remarkably well tolerated. While fever alone requires no treatment, when associated with discomfort or pain, paracetamol offers relief. Also, for mild to moderate pain, paracetamol, either alone or in combination with another drug, is effective. Even in severe pain, paracetamol offers a significant additive analgesic effect to opiates. Globally, the pediatric dose varies between 10 and 15 mg/kg. In the United Kingdom, 10 mg/kg is given every 4 hours, up to a maximum of four doses per day; in Australia, 15 mg/kg is administered 4-hourly up to a total dose of 60 mg/kg/day. In overdose, paracetamol is hepatotoxic. Single ingestions of more than ten times the recommended dose are potentially toxic. The development of specific antidotes and the universal availability of the Rumack-Matthew Nomogram have made the early treatment of overdose effective without long-term sequelae. There are sporadic case reports of chronic overdosing resulting in liver failure. Although the specific predictors are still being defined, exposures greater than 140 mg/kg/day for several days carry a risk of serious toxicity. In children, aspirin use has almost disappeared with the concurrent decline in Reye Syndrome. Less clinical experience has accumulated with ibuprofen, and it remains the second-line treatment for fever and pain. In conclusion, paracetamol remains the first-choice over-the-counter treatment for analgesia and antipyresis in children.