Abstract

Background:Paracetamol (acetaminophen) is one of the most widely used Over-The-Counter (OTC) analgesics for the self-treatment of mild to moderate acute pain. Different dosages are used in different countries and, in some of them, a large proportion of adults are using low doses (325 mg to 500 mg).Objectives:The objective of the study was to review information from published research studies to answer the question: is there a dose-dependent analgesic effect of paracetamol in the treatment of mild to moderate acute pain?Methods:A detailed assessment of available systematic reviews, meta-analyses and single randomised trials was undertaken based on an electronic literature search focusing on studies comparing higher and lower doses of paracetamol in the management of mild to moderate acute pain.Results:Reviews and comparative trials generally showed greater efficacy with higher dose paracetamol (1000 mg) than with lower doses (500 mg or 650 mg) in achieving clinically significant pain relief with comparable tolerability in different types of pain.ConclusionsThe nature and intensity of the pain are two key elements of the therapeutic choice.Higher dose immediate-release paracetamol (1000 mg), used for a short duration of time (4-5 days) and adhering to recommendations within the label for risk groups, delivers safe and more effective analgesia than lower doses for adults with mild to moderate acute pain.Strengths and Limitations of this Study:• Paracetamol is one of the most widely used OTC analgesics for the self- treatment of mild to moderate acute pain and this study aims to explore the practical question of whether the use of low doses, which is common in some countries, provides suboptimal pain relief.• This review provides an overview of previous studies focusing on comparing the analgesic efficacy of different doses of paracetamol rather than comparing the effect of different OTC analgesics.• This review details a narrative assessment of available systematic reviews, meta-analysis and randomised trials but does not offer a quantitative analysis of pain relief achieved with different doses of paracetamol.• The review does not provide an overview of studies focusing on different forms of paracetamol.• The focus for this review is immediate release paracetamol. Combined and slow release paracetamol formulations were not considered of relevance. The latter are in the process of being suspended across the European Union due to safety concerns with overdosing [1].

Highlights

  • Paracetamol is one of the most widely used Over-The-Counter (OTC) analgesics for the self-treatment of mild to moderate acute pain

  • The study authors searched the published literature systematically for randomised, double-blind clinical trials comparing at least two doses of paracetamol with placebo or an active comparator in pain including a minimum of 10 patients in each treatment group

  • They carried out two levels of analysis: first taking a broad approach to which trials they included, looking at trials reporting results on pain intensity or pain relief over a four to six hour period and second including only those trials carried out in patients with initial pain that was at least moderate in intensity and that included at least 10 patients in each treatment arm

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Summary

Introduction

Paracetamol (acetaminophen) is one of the most widely used Over-The-Counter (OTC) analgesics for the self-treatment of mild to moderate acute pain. Paracetamol is one of the most commonly used Over-The-Counter (OTC) analgesics in the self-treatment of acute mild to moderate pain [2]. A systematic review of patients’ views has shown that pain sufferers want to achieve either a substantial reduction in their pain intensity of 50% or more, or to achieve a low pain state, with no worse than mild pain [6]. They want substantial improvement in the impaired quality of life, fatigue and distress that are generally associated with being in pain [6]. Good efficacy and rapid onset of pain relief can reduce the risk of excessive dosing with an analgesic [8]

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