A narrative systematic review of the safety and effectiveness of oral transmucosal fentanyl citrate in the management of acute traumatic pain

Introduction Adequate analgesia is an essential element of patient care. A recent investigation into a UK major incident (MI) highlighted that delivery of analgesia during it was inadequate. A subsequent inquiry suggested that oral transmucosal fentanyl citrate (OTFC) may improve delivery of analgesia in this setting. This systematic review aims to determine the most effective and safest dose of OTFC in the context of a MI for adults, children, the frail and elderly, and the hypovolaemic. Methods A literature search of MEDLINE, CINAHL, and Embase was conducted, searching for articles containing original data in human subjects with no restriction for language. Hand-searching of all articles was also undertaken. Data from included papers were extracted into a template and risk of bias assessment completed using the Cochrane RoB2 tool. A random effects model was planned for meta-analysis. Results 28 papers were included. 13 reported adult data (1227 individuals), one reported on the frail and elderly (five individuals) and 14 reported on children (593 individuals). 18 of the papers were randomised controlled trials; the remainder were observational studies. The heterogeneity of papers precluded meta-analysis. In adults, a dose of 800mcg provided the best balance between effectiveness and safety. For children, 10–15mcg/kg had a similar profile. Effectiveness was good, with most patients showing a clinically significant reduction in pain. Serious adverse events were rare, although minor side effects were more prevalent. Discussion The lack of evidence originating from MIs and in some groups of interest is the greatest limitation of this study. However, we are confident to recommend that in adults 18–65 years of age, who are responsive to voice, 800mcg of OTFC would provide safe and effective analgesia. In children >5 years of age, who are responsive to voice, 10–15mcg/kg of OTFC will provide safe and effective analgesia.