How Safe Are Common Analgesics for the Treatment of Acute Pain for Children? A Systematic Review.

Lisa Hartling,Antonia Stang,Samina Ali,Amy L Drendel,Donna M Dryden,Pritam Chordiya,David W Johnson,Amy C Plint,Patrick J Mcgrath

doi:10.1155/2016/5346819

Abstract

Background. Fear of adverse events and occurrence of side effects are commonly cited by families and physicians as obstructive to appropriate use of pain medication in children. We examined evidence comparing the safety profiles of three groups of oral medications, acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids, to manage acute nonsurgical pain in children (<18 years) treated in ambulatory settings. Methods. A comprehensive search was performed to July 2015, including review of national data registries. Two reviewers screened articles for inclusion, assessed methodological quality, and extracted data. Risks (incidence rates) were pooled using a random effects model. Results. Forty-four studies were included; 23 reported on adverse events. Based on limited current evidence, acetaminophen, ibuprofen, and opioids have similar nausea and vomiting profiles. Opioids have the greatest risk of central nervous system adverse events. Dual therapy with a nonopioid/opioid combination resulted in a lower risk of adverse events than opioids alone. Conclusions. Ibuprofen and acetaminophen have similar reported adverse effects and notably less adverse events than opioids. Dual therapy with a nonopioid/opioid combination confers a protective effect for adverse events over opioids alone. This research highlights challenges in assessing medication safety, including lack of more detailed information in registry data, and inconsistent reporting in trials.

Highlights

Pain is the most common reason for seeking healthcare in the Western world [1,2,3]
We contacted the U.S Food and Drug Administration (FDA) and Health Canada for safety data related to the medications of interest
We present a summary of Adverse event Central Nervous System (CNS) (AE) by treatment arm for an overall picture of which interventions had a high risk of specific AEs

Summary

Introduction

Pain is the most common reason for seeking healthcare in the Western world [1,2,3]. Key organizations have voiced concern with our medical services’ inability to provide appropriate analgesia for children’s pain [4,5,6,7,8]. Fear of adverse events (AEs) is commonly cited by both families and physicians as an obstruction to appropriate use of analgesic medication in childhood [13, 14]. Comprehensive drug safety in children remains understudied, despite emerging evidence that AEs are frequent and are commonly cited as a reason for terminating prescribed therapy [15, 16]. AEs may discourage future use of analgesics, thereby exposing children to unnecessary pain and its resultant negative consequences. Fear of adverse events and occurrence of side effects are commonly cited by families and physicians as obstructive to appropriate use of pain medication in children. Dual therapy with a nonopioid/opioid combination resulted in a lower risk of adverse events than opioids alone. This research highlights challenges in assessing medication safety, including lack of more detailed information in registry data, and inconsistent reporting in trials

Methods

Results

Discussion

Conclusion